Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 08, 2016 | Jun. 30, 2015 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Synthetic Biologics, Inc. | ||
Entity Central Index Key | 894,158 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 173.5 | ||
Trading Symbol | SYN | ||
Entity Common Stock, Shares Outstanding | 90,826,752 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current Assets | ||
Cash and cash equivalents | $ 20,818 | $ 17,525 |
Prepaid expenses and other current assets | 9,519 | 1,548 |
Total Current Assets | 30,337 | 19,073 |
Property and equipment, net | 494 | 65 |
Deposits and other assets | 14 | 6 |
Total Assets | 30,845 | 19,144 |
Current Liabilities: | ||
Accounts payable | 4,413 | 996 |
Accrued expenses | 297 | 1,298 |
Warrant liabilities | 10,567 | 6,756 |
Accrued employee benefits | 277 | 538 |
Deferred rent | 21 | 0 |
Total Current Liabilities | 15,575 | 9,588 |
Long term deferred rent | 267 | 0 |
Total Liabilities | $ 15,842 | $ 9,588 |
Commitments and Contingencies | ||
Equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized, none issued and outstanding | $ 0 | $ 0 |
Common stock, $0.001 par value; 250,000,000 shares authorized, 90,908,234 issued and 90,826,752 outstanding, and 100,000,000 shares authorized, 72,594,626 issued and 72,513,144 outstanding, respectively | 91 | 72 |
Additional paid-in capital | 160,739 | 110,526 |
Accumulated deficit | (144,779) | (101,042) |
Total Synthetic Biologics, Inc. and Subsidiaries Equity | 16,051 | 9,556 |
Non-controlling interest | (1,048) | 0 |
Total Stockholders' Equity | 15,003 | 9,556 |
Total Liabilities and Stockholders' Equity | $ 30,845 | $ 19,144 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 100,000,000 |
Common stock, shares, issued | 90,908,234 | 72,594,626 |
Common stock, shares outstanding | 90,826,752 | 72,513,144 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating Costs and Expenses: | |||
General and administrative | $ 8,074 | $ 6,013 | $ 5,832 |
Research and development | 32,906 | 14,489 | 6,507 |
Total Operating Costs and Expenses | 40,980 | 20,502 | 12,339 |
Loss from Operations | (40,980) | (20,502) | (12,339) |
Other Income (Expense): | |||
Change in fair value of warrant liability | (3,811) | 620 | 0 |
Other income (expense) | 0 | 95 | (12) |
Interest income | 6 | 3 | 33 |
Total Other Income (Expense) | (3,805) | 718 | 21 |
Net Loss | (44,785) | (19,784) | (12,318) |
Net Loss Attributable to Non-controlling Interest | (1,048) | 0 | (1) |
Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries | $ (43,737) | $ (19,784) | $ (12,317) |
Net Loss Per Share - Basic and Dilutive (in dollars per share) | $ (0.54) | $ (0.32) | $ (0.27) |
Net Income (Loss) Per Share - Basic and Dilutive | |||
Weighted average number of shares outstanding during the period - Basic and Dilutive (in shares) | 80,705,692 | 61,945,356 | 45,667,813 |
Consolidated Statements of Equi
Consolidated Statements of Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Noncontrolling Interest [Member] |
Balance at Dec. 31, 2012 | $ 13,028 | $ 44 | $ 81,925 | $ (68,941) | $ 0 |
Balance (in shares) at Dec. 31, 2012 | 44,362,748 | ||||
Stock-based compensation | 1,669 | $ 0 | 1,669 | 0 | 0 |
Issuance of common stock, net of issuance costs | 12,193 | $ 13 | 12,180 | 0 | 0 |
Issuance of common stock, net of issuance costs (in shares) | 13,225,000 | ||||
Issuance of common stock for exercise of stock options | 232 | $ 1 | 231 | 0 | 0 |
Issuance of common stock for exercise of stock options (in shares) | 291,667 | ||||
Issuance of common stock for license agreement | 425 | $ 0 | 425 | 0 | 0 |
Issuance of common stock for license agreement (in shares) | 334,911 | ||||
Issuance of stock | 1 | $ 0 | 0 | 0 | 1 |
Issuance of stock (in shares) | 0 | ||||
Net loss | (12,317) | $ 0 | 0 | (12,317) | (1) |
Non-controlling interest | (1) | ||||
Balance at Dec. 31, 2013 | 15,230 | $ 58 | 96,430 | (81,258) | 0 |
Balance (in shares) at Dec. 31, 2013 | 58,214,326 | ||||
Stock-based compensation | 2,459 | $ 0 | 2,459 | 0 | 0 |
Issuance of common stock, net of issuance costs | 11,647 | $ 14 | 11,633 | 0 | 0 |
Issuance of common stock, net of issuance costs (in shares) | 14,059,616 | ||||
Issuance of common stock for exercise of stock options | 4 | $ 0 | 4 | 0 | 0 |
Issuance of common stock for exercise of stock options (in shares) | 6,583 | ||||
Issuance of common stock for cashless exercise of warrants | 0 | $ 0 | 0 | 0 | 0 |
Issuance of common stock for cashless exercise of warrants (in shares) | 232,619 | ||||
Net loss | (19,784) | $ 0 | 0 | (19,784) | 0 |
Non-controlling interest | 0 | ||||
Balance at Dec. 31, 2014 | 9,556 | $ 72 | 110,526 | (101,042) | 0 |
Balance (in shares) at Dec. 31, 2014 | 72,513,144 | ||||
Stock-based compensation | 3,198 | $ 0 | 3,198 | 0 | 0 |
Issuance of common stock, net of issuance costs | 42,643 | $ 16 | 42,627 | 0 | 0 |
Issuance of common stock, net of issuance costs (in shares) | 15,333,333 | ||||
Stock issued for milestone payments | 1,350 | $ 2 | 1,348 | 0 | 0 |
Stock issued for milestone payments (in Shares) | 2,005,321 | ||||
Issuance of common stock for exclusive channel collaboration agreement | 3,000 | $ 1 | 2,999 | 0 | 0 |
Issuance of common stock for exclusive channel collaboration agreement (in shares) | 937,500 | ||||
Issuance of common stock for exercise of stock options | 41 | $ 0 | 41 | 0 | 0 |
Issuance of common stock for exercise of stock options (in shares) | 35,008 | ||||
Issuance of common stock for cashless exercise of warrants | 0 | $ 0 | 0 | 0 | 0 |
Issuance of common stock for cashless exercise of warrants (in shares) | 2,446 | ||||
Net loss | (43,737) | $ 0 | 0 | (43,737) | 0 |
Non-controlling interest | (1,048) | 0 | 0 | 0 | (1,048) |
Balance at Dec. 31, 2015 | $ 15,003 | $ 91 | $ 160,739 | $ (144,779) | $ (1,048) |
Balance (in shares) at Dec. 31, 2015 | 90,826,752 |
Consolidated Statements of Equ6
Consolidated Statements of Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stock Issuance Costs | $ 3,357 | $ 1,645 | $ 1,031 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash Flows From Operating Activities: | |||
Net Loss | $ (44,785) | $ (19,784) | $ (12,318) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation | 3,198 | 2,459 | 1,669 |
Stock issued for milestone payments | 1,350 | 0 | 0 |
Stock issued for exclusive channel collaboration agreement | 3,000 | 0 | 0 |
Stock issued for license agreement | 0 | 0 | 425 |
Change in fair value of warrant liabilities | 3,811 | (620) | 0 |
Depreciation and amortization | 72 | 20 | 43 |
Provision for uncollectible note and interest receivables | 0 | 0 | 763 |
Loss on sale of equipment | 0 | 0 | 58 |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | (7,971) | 43 | 855 |
Deposits and other assets | (8) | (2) | 33 |
Accounts payable | 3,417 | 854 | (253) |
Accrued expenses | (1,001) | 416 | 885 |
Accrued employee benefits | (261) | 535 | 0 |
Deferred rent | 288 | 0 | 0 |
Impairment loss on equipment | 0 | 0 | 121 |
Net Cash Used In Operating Activities | (38,890) | (16,079) | (7,719) |
Cash Flows From Investing Activities: | |||
Purchases of property and equipment | (501) | (48) | (36) |
Net Cash Used In Investing Activities | (501) | (48) | (36) |
Cash Flows From Financing Activities: | |||
Proceeds from issuance of common stock | 46,000 | 20,668 | 13,224 |
Cash paid as direct offering costs | (3,357) | (1,645) | (1,031) |
Proceeds from issuance of common stock for stock option exercises | 41 | 4 | 232 |
Cash received from issuance of stock to non-controlling interest | 0 | 0 | 1 |
Net Cash Provided By Financing Activities | 42,684 | 19,027 | 12,426 |
Net increase in cash | 3,293 | 2,900 | 4,671 |
Cash at beginning of year | 17,525 | 14,625 | 9,954 |
Cash at end of year | 20,818 | 17,525 | 14,625 |
Supplemental disclosures of cash flow information: | |||
Cash paid for interest | 0 | 0 | 0 |
Cash paid for taxes | $ 0 | $ 0 | $ 0 |
Organization and Nature of Oper
Organization and Nature of Operations and Basis of Presentation | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 1. Organization and Nature of Operations and Basis of Presentation Description of Business Synthetic Biologics, Inc. (the “Company” or “Synthetic Biologics”) is a clinical stage company developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development are: (1) SYN-010 which is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and (2) SYN-004 which is designed to protect the gut microbiome (gastrointestinal (GI) microflora) from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile At December 31, 2015, the Company had cash and cash equivalents of approximately $20.8 million. Management believes that the Company’s current cash on hand will be sufficient to fund its operations for at least the foreseeable future. The Company will ultimately be required to obtain additional funding in order to execute its long-term business plans, although it does not currently have commitments from any third parties to provide it with capital. The Company cannot assure that additional funding will be available on favorable terms, or at all. If the Company fails to obtain additional funding when needed, it may not be able to execute its business plans and its business may suffer, which would have a material adverse effect on its financial position, results of operations and cash flows. Basis of Presentation and Corporate Structure As of December 31, 2015, the Company had eight subsidiaries, Pipex Therapeutics, Inc. (“Pipex Therapeutics”), Effective Pharmaceuticals, Inc. (“EPI”), Solovax, Inc. (“Solovax”), CD4 Biosciences, Inc. (“CD4”), Epitope Pharmaceuticals, Inc. (“Epitope”), Healthmine, Inc. (“Healthmine”), Putney Drug Corp. (“Putney”) and Synthetic Biomics, Inc. (“SYN Biomics”). Pipex Therapeutics, EPI, Healthmine and Putney are wholly owned, and Solovax, CD4, Epitope and SYN Biomics are majority-owned. For financial reporting purposes, the outstanding common stock of the Company is that of Synthetic Biologics, Inc. All statements of operations, equity and cash flows for each of the entities are presented as consolidated. All subsidiaries were formed under the laws of the State of Delaware on January 8, 2001, except for EPI, which was incorporated in Delaware on December 12, 2000, Epitope which was incorporated in Delaware in January of 2002, Putney which was incorporated in Delaware in November of 2006, Healthmine which was incorporated in Delaware in December of 2007 and SYN Biomics which was incorporated in Nevada in December of 2013. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies [Text Block] | 2. Summary of Significant Accounting Policies Principles of Consolidation All inter-company transactions and accounts have been eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Such estimates and assumptions impact, among others, the following: the estimated useful lives for property and equipment, fair value of warrants and stock options granted for services or compensation, respectively, estimates of the probability and potential magnitude of contingent liabilities, and the valuation allowance for deferred tax assets due to continuing and expected future operating losses. Making estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the date of the consolidated financial statements, which management considered in formulating its estimate could change in the near term due to one or more future confirming events. Accordingly, actual results could differ from those estimates. Non-controlling Interest The Company’s non-controlling interest represents the minority shareholder’s ownership interest related to the Company’s subsidiary, SYN Biomics. The Company reports its non-controlling interest in subsidiaries as a separate component of equity in the Consolidated Balance Sheets and reports both net loss attributable to the non-controlling interest and net loss attributable to the Company’s common shareholders on the face of the consolidated Statements of Operations. The Company’s equity interest in SYN Biomics is 88.5% and the non-controlling stockholder’s interest is 11.5%. This is reflected in the Consolidated Statements of Equity. Revenue Recognition The Company records revenue when all of the following have occurred: (1) persuasive evidence of an arrangement exists, (2) the service is completed without further obligation, (3) the sales price to the customer is fixed or determinable, and (4) collectability is reasonably assured. The Company recognizes milestone payments or upfront payments that have no contingencies as revenue when payment is received. For the years ended December 31, 2015, 2014 and December 31, 2013 the Company did not report any revenues. License Revenues The Company’s licensing agreements may contain multiple elements, such as non-refundable up-front fees, payments related to the achievement of particular milestones and royalties. Fees associated with substantive at risk performance-based milestones are recognized as revenue upon completion of the scientific or regulatory event specified in the agreement. When the Company has substantive continuing performance obligations under an arrangement, revenue is recognized over the performance period of the obligations using a time-based proportional performance approach. Under the time-based method, revenue is recognized over the arrangement’s estimated performance period based on the elapsed time compared to the total estimated performance period. Revenue recognized at any point in time is limited to the amount of non-contingent payments received or due. When the Company has no substantive continuing performance obligations under an arrangement, it recognizes revenue as the related fees become due. Revenues from royalties on third-party sales of licensed technologies are generally recognized in accordance with the contract terms when the royalties can be reliably determined and collectability is reasonably assured. To date, the Company has not received any royalty revenues. Risks and Uncertainties The Company’s operations could be subject to significant risks and uncertainties including financial, operational and regulatory risks and the potential risk of business failure. The global economic crisis has caused a general tightening in the credit markets, lower levels of liquidity, increases in the rates of default and bankruptcy, and extreme volatility in credit, equity and fixed income markets. These conditions may not only limit the Company’s access to capital, but also make it difficult for its customers, its vendors and its ability to accurately forecast and plan future business activities. Cash and Cash Equivalents Cash and cash equivalents include cash and highly liquid short-term investments with original maturities of three months or less. Property and Equipment Property and equipment is recorded at cost and depreciated or amortized using the straight-line method over the estimated useful life of the asset or the underlying lease term for leasehold improvements, whichever is shorter. The estimated useful life by asset description is noted in the following table. Asset Description Estimated Useful Life Office equipment and furniture 3 5 years Manufacturing equipment 10 years Leasehold improvements and fixtures Lesser of estimated useful or life of lease Depreciation and amortization expense was approximately $72,000, $20,000 and $43,000 for the years ended December 31, 2015, 2014 and 2013, respectively. When assets are disposed of, the cost and accumulated depreciation are removed from the accounts. Repairs and maintenance are charged to expense as incurred. The Company reviews property and equipment for impairment to determine if assets are impaired due to obsolescence. As a result of this review, the Company recorded impairment losses of approximately $0, $0 and $121,000 for the years ended December 31, 2015, 2014 and 2013, respectively. Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such an event or change in circumstances occurs and potential impairment is indicated because the carrying values exceed the estimated future undiscounted cash flows of the asset, the Company will measure the impairment loss as the amount by which the carrying value of the asset exceeds its fair value. Net Income (Loss) per Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding including the effect of common share equivalents. Diluted net loss per share assumes the issuance of potential dilutive common shares outstanding for the period and adjusts for any changes in income and the repurchase of common shares that would have occurred from the assumed issuance, unless such effect is anti-dilutive. The number of options and warrants for the purchase of common stock that were excluded from the computations of net loss per common share for the year ended December 31, 2015 were 8,941,930 and 7,908,899, respectively, for the year ended December 31, 2014 were 5,981,106 and 7,974,794, respectively, and for the year ended December 31, 2013 were 3,909,580 and 1,632,501, respectively. Research and Development Costs The Company expenses research and development costs associated with developmental products not yet approved by the FDA to research and development expense as incurred. Research and development costs consist primarily of license fees (including upfront payments), milestone payments, manufacturing costs, salaries, stock-based compensation and related employee costs, fees paid to consultants and outside service providers for laboratory development, legal expenses resulting from intellectual property prosecution and other expenses relating to the design, development, testing and enhancement of our product candidates. Research and development expenses include external contract research organization (“CRO”) services. The Company makes payments to the CROs based on agreed upon terms and may include payments in advance of study services. The Company reviews and accrues CRO expenses based on services performed and rely on estimates of those costs applicable to the stage of completion of a study as provided by the CRO. Accrued CRO costs are subject to revisions as such studies progress to completion. The Company has accrued CRO expenses of $2.2 million and $525,000 that are included in accounts payable and accrued expenses at December 31, 2015 and 2014. The Company has prepaid CRO costs of $8.3 million and $0 at December 31, 2015 and 2014. Fair Value of Financial Instruments The fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows: • Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; • Level 2 inputs: Inputs, other than quoted prices, included in Level 1 that are observable either directly or indirectly; and • Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy. The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, other current assets, accounts payable and accrued liabilities approximate fair value due to the relatively short period to maturity for these instruments. Cash and cash equivalents include money market accounts of $5.3 million and $13.6 million as of December 31, 2015 and December 31, 2014, respectively, that are measured using Level 1 inputs. The warrants issued in conjunction with the registered direct offering in October 2014 include a provision, that if the Company were to enter into certain transactions, as defined in the agreement, the warrants would be purchased from the holder at a premium. Accordingly, the Company recorded the warrants as liabilities at their fair value upon issuance and re-measures the fair value at each period end with the change in fair value recorded in the Statement of Operations. The Company uses the Black-Scholes options pricing model to estimate the fair value of the warrants. In using this model, the fair value is determined by applying Level 3 inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions. The assumptions used in calculating the estimated fair value of the warrants represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the warrant liability and the change in estimated fair value could be materially different. Stock-Based Payment Arrangements Generally, all forms of stock-based payments, including stock option grants, warrants, restricted stock grants and stock appreciation rights are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model, based on the estimated number of awards that are ultimately expected to vest. Stock-based compensation awards issued to non-employees for services rendered are recorded at either the fair value of the services rendered or the fair value of the stock-based payment, whichever is more readily determinable and are re-measured over the corresponding vesting period. The expense resulting from stock-based payments is recorded in research and development expense or general and administrative expense in the consolidated statement of operations, depending on the nature of the services provided. Derivative Instruments The warrants issued in conjunction with the registered direct offering in October 2014 include a provision, that if the Company were to enter into a certain transaction, as defined in the agreement, the warrants would be purchased from the holder at a premium. The reset provision of these warrants preclude equity accounting treatment under ASC 815. Accordingly, the Company is required to record the warrants as liabilities at their fair value upon issuance and re-measure the fair value at each period end with the change in fair value recorded in the Statement of Operations. When the warrants are exercised or cancelled, they are reclassified to equity. The Company uses the Black-Scholes options pricing model to estimate the fair value of the warrants. Income Taxes The Company recognizes deferred tax liabilities and assets based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all deferred tax assets will not be realized. Management assesses the need to accrue or disclose uncertain tax positions for proposed potential adjustments from various federal and state authorities who regularly audit the Company in the normal course of business. In making these assessments, management must often analyze complex tax laws of multiple jurisdictions. The Company records the related interest expense and penalties, if any, as tax expense in the tax provision. At December 31, 2015 and 2014, respectively, the Company did not record any liabilities for uncertain tax positions. Recent Accounting Pronouncements and Developments In November 2015, the FASB issued Accounting Standards Update (“ASU”) 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes, simplifying the balance sheet classification of deferred taxes by requiring all deferred taxes, along with any related valuation allowance, to be presented as noncurrent. This ASU is effective for the Company beginning in the first quarter of 2017, allows for early adoption and may be applied either prospectively or retrospectively. This ASU is not expected to have a material impact on the Company’s Consolidated Financial Statements. In January 2016, the FASB issued ASU No. 2016-01, “Financial Instruments Overall: Recognition and Measurement of Financial Assets and Financial Liabilities” (“ASU 2016-01”). The guidance affects the accounting for equity investments, financial liabilities under the fair value option and the presentation and disclosure requirements of financial instruments. The guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company is evaluating the effect that ASU 2016-01 will have on its consolidated financial statements and related disclosures. In February of 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)” (“ASU 2016-02”). Under ASU 2016-02, an entity will be required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. ASU 2016-02 offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. For public companies, ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period, and requires a modified retrospective adoption, with early adoption permitted. We are in the process of evaluating the future impact of ASU 2016-02 on our consolidated financial position, results of operations and cash flows. |
Selected Balance Sheet Informat
Selected Balance Sheet Information | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Supplemental Balance Sheet Disclosures [Text Block] | 3. Selected Balance Sheet Information Prepaid expenses and other current assets (in thousands): December 31, 2015 2014 Intrexon prepaid research and development expenses See Note 7 $ 643 $ 1,067 Prepaid clinical research organization expenses 8,329 Prepaid insurances 339 228 Other prepaid expenses 208 253 Total $ 9,519 $ 1,548 The Intrexon prepaid research and development expenses are classified as a current asset. The Company may terminate the arrangement at any time and receive a cash refund of the remaining balance minus any amounts owed to Intrexon. The Company anticipates that the majority of the prepaid will be applied to research and development expenses during 2016. Prepaid clinical research organization expense are classified as a current asset. The Company makes payments to the clinical research organizations based on agreed upon terms that includes payments in advance of study services. The Company anticipates that the majority of the prepaid clinical research organization expenses will be applied to research and development expenses during 2016. Property and equipment (in thousands): December 31, 2015 2014 Computer and office equipment $ 346 $ 93 Software 11 11 Leasehold improvements 242 599 104 Less accumulated depreciation and amortization (105 ) (39 ) Total $ 494 $ 65 Accrued expenses (in thousands): December 31, 2015 2014 Accrued manufacturing costs $ $ 247 Accrued vendor payments 133 176 Accrued milestones payments 350 Accrued clinical consulting services 164 525 Total $ 297 $ 1,298 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 4. Stock-Based Compensation Stock Incentive Plan During 2001, the Company’s Board of Directors and stockholders adopted the 2001 Stock Incentive Plan (the “2001 Stock Plan”). The total number of shares of stock with respect to which stock options and stock appreciation rights may be granted to any one employee of the Company or a subsidiary during any one-year period under the 2001 Stock Plan shall not exceed 250,000. All awards pursuant to the 2001 Stock Plan shall terminate upon the termination of the grantee’s employment for any reason. Awards include options, restricted shares, stock appreciation rights, performance shares and cash-based awards (the “Awards”). The 2001 Stock Plan contains certain anti-dilution provisions in the event of a stock split, stock dividend or other capital adjustment, as defined in the plan. The 2001 Stock Plan provides for a Committee of the Board to grant awards and to determine the exercise price, vesting term, expiration date and all other terms and conditions of the awards, including acceleration of the vesting of an award at any time. As of December 31, 2015, there were 671,607 options issued and outstanding under the 2001 Stock Plan. On March 20, 2007, the Company’s Board of Directors approved the 2007 Stock Incentive Plan (the “2007 Stock Plan”) for the issuance of up to 2,500,000 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. This plan was approved by stockholders on November 2, 2007. The exercise price of stock options under the 2007 Stock Plan is determined by the compensation committee of the Board of Directors, and may be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. The total number of shares of stock with respect to which stock options and stock appreciation rights may be granted to any one employee of the Company or a subsidiary during any one-year period under the 2007 plan shall not exceed 250,000. Options become exercisable over various periods from the date of grant, and generally expire ten years after the grant date. As of December 31, 2015, there were 428,657 options issued and outstanding under the 2007 Stock Plan. On November 2, 2010, the Board of Directors and stockholders adopted the 2010 Stock Incentive Plan (“2010 Stock Plan”) for the issuance of up to 3,000,000 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. On October 22, 2013, the stockholders approved and adopted an amendment to the Company’s 2010 Incentive Stock Plan to increase the number of shares of Company’s common stock reserved for issuance under the Plan from 3,000,000 to 6,000,000. On May 15, 2015, the stockholders approved and adopted an amendment to the Company’s 2010 Incentive Stock Plan to increase the number of shares of the Company’s common stock reserved for issuance under the Plan from 6,000,000 to 8,000,000. The exercise price of stock options under the 2010 Stock Plan is determined by the compensation committee of the Board of Directors, and may be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. Options become exercisable over various period from the date of grant, and expire between five and ten years after the grant date. As of December 31, 2015, there were 7,841,666 options issued and outstanding under the 2010 Stock Plan. In the event of an employee’s termination, the Company will cease to recognize compensation expense for that employee. There is no deferred compensation recorded upon initial grant date, instead, the fair value of the stock-based payment is recognized ratably over the stated vesting period. The Company has applied fair value accounting for all share based payment awards since inception. The fair value of each option or warrant granted is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes assumptions used in the years ended December 31, 2015, 2014 and 2013 are as follows: Year ended December 31, 2015 2014 2013 Exercise price $ 1.54 $2.76 $ 1.46 $2.91 $ 1.64 $1.74 Expected dividends 0% 0% 0% Expected volatility 88% 131% 101% 150% 141% 154% Risk free interest rate 1.32% 2.19% 1.57% 2.73% 0.77% 2.54% Expected life of option 5 years 10 years 5 years 10 years 5 years 10 years The Company records stock-based compensation based upon the stated vested provisions in the related agreements. The vesting provisions for these agreements have various terms as follows: • immediate vesting, • half vesting immediately and remaining over three years, • quarterly over three years, • annually over three years, • one-third immediate vesting and remaining annually over two years, • one-half immediate vesting and remaining over nine months, • one-quarter immediate vesting and remaining over three years, • one-quarter immediate vesting and remaining over 33 months; and • monthly over three years. During the years ended December 31, 2015, 2014 and 2013 the Company granted 3,781,666, 2,382,500 and 222,500 options to employees and directors having an approximate fair value of $8.0 million, $5.0 million and $350,000 based upon the Black-Scholes options pricing model, respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to employees for the years ended December 31, 2015, 2014 and 2013 was $2.3 million, $2.1 million and $1.3 million, respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to consultants for the years ended December 31, 2015, 2014 and 2013 were $888,000, $380,000 and $324,000, respectively. Options Weighted Weighted Aggregate Balance December 31, 2012 4,453,746 $ 1.78 6.43 years $ 1,308,000 Granted 222,500 $ 1.69 Exercised (291,666 ) $ 0.79 $ 71,000 Forfeited (475,000 ) $ 2.30 Balance December 31, 2013 3,909,580 $ 1.78 5.59 years $ 785,000 Granted 2,382,500 $ 2.36 Exercised (6,583 ) $ 0.58 $ 8,000 Forfeited (304,391 ) $ 1.93 Balance December 31, 2014 5,981,106 $ 2.01 5.80 years $ 685,000 Granted 3,781,666 $ 2.37 Exercised (35,008 ) $ 1.16 $ 44,000 Expired (483,332 ) $ 2.48 Forfeited (302,502 ) $ 1.91 Balance December 31, 2015 outstanding 8,941,930 $ 2.14 5.67 years $ 2,900,000 Balance December 31, 2015 exercisable 4,757,754 $ 1.92 4.54 years $ 2,272,000 Grant date fair value of options granted 2015 $ 7,974,000 Weighted average grant date fair value 2015 $ 2.12 Grant date fair value of options granted 2014 $ 4,974,000 Weighted average grant date fair value 2014 $ 2.09 Grant date fair value of options granted 2013 $ 350,000 Weighted average grant date fair value 2013 $ 1.57 The options outstanding and exercisable at December 31, 2015 are as follows: Options Outstanding Options Exercisable Range of Options Weighted Weighted Options Weighted Weighted $ 0.09 $2.00 3,029,938 $ 1.40 4.12 years 2,363,683 $ 1.34 3.38 years $ 2.01 $3.00 5,866,168 2.50 6.50 years 2,348,247 2.44 5.76 years $ 3.01 $6.00 45,824 5.24 1.62 years 45,824 5.24 1.62 years $ 0.09 $6.00 8,941,930 $ 2.14 5.67 years 4,757,754 $ 1.92 4.54 years The options outstanding and exercisable at December 31, 2014 are as follows: Options Outstanding Options Exercisable Range of Options Weighted Weighted Options Weighted Weighted $ 0.09 $2.00 2,703,280 $ 1.37 4.33 years 2,018,074 $ 1.28 3.73 years $ 2.01 $3.00 3,232,002 2.49 7.08 years 1,829,298 2.40 6.73 years $ 3.01 $6.00 45,824 5.24 2.62 years 45,824 5.24 2.62 years $ 0.09 $6.00 5,981,106 $ 2.01 5.80 years 3,893,196 $ 1.85 5.12 years The options outstanding and exercisable at December 31, 2013 are as follows: Options Outstanding Options Exercisable Range of Options Weighted Weighted Options Weighted Weighted $ 0.09 $2.00 2,093,196 $ 1.29 4.73 years 1,901,737 $ 1.25 4.64 years $ 2.01 $3.00 1,770,560 2.28 6.65 years 1,205,976 2.26 6.25 years $ 3.01 $6.00 45,824 5.24 3.62 years 45,824 5.24 3.62 years $ 0.09 $6.00 3,909,580 $ 1.78 5.59 years 3,153,537 $ 1.69 5.24 years The following is a summary of the Company’s non-vested stock options at December 31, 2015: Unvested Weighted Balance December 31, 2012 1,561,869 $ 2.11 Granted 222,500 $ 1.57 Vested/Exercised (883,882 ) $ 1.93 Forfeited/Cancelled (144,444 ) $ 2.27 Balance December 31, 2013 756,043 $ 2.17 Granted 2,382,500 $ 2.09 Vested/Exercised (1,050,633 ) $ 2.35 Balance December 31, 2014 2,087,910 $ 2.30 Granted 3,781,666 $ 2.12 Vested/Exercised (1,382,898 ) $ 2.02 Forfeited/Cancelled (302,502 ) $ 1.92 Non-vested December 31, 2015 4,184,176 $ 1.97 Weighted average remaining period for vesting 2.36 years As of December 31, 2015, total unrecognized stock-based compensation expense related to stock options was $8.3 million, which is expected to be expensed through April 2018. FASB’s guidance for stock-based payments requires cash flows from excess tax benefits to be classified as a part of cash flows from financing activities. Excess tax benefits are realized tax benefits from tax deductions for exercised options in excess of the deferred tax asset attributable to stock compensation costs for such options. The Company did not record any excess tax benefits in 2015, 2014 or 2013. Cash received from option exercises under the Company’s stock-based compensation plans for the years ended December 31, 2015, 2014 and 2013 was $41,000, $4,000 and $232,000, respectively. Stock Warrants On October 10, 2014, the Company raised net proceeds of $19.1 million through the sale of 14,059,616 units at a price of $1.47 per unit to certain institutional investors in a registered direct offering. Each unit consisted of one share of the Company’s common stock and a warrant to purchase 0.5 shares of common stock. The warrants, exercisable for an aggregate of 7,029,808 shares of common stock, have an exercise price of $1.75 per share and a life of five years. The warrants vested immediately and expire October 10, 2019. The warrants issued in conjunction with the registered direct offering in October 2014 include a provision, that if the Company were to enter into a certain transaction, as defined in the agreement, the warrants would be purchased from the holder at a premium. Accordingly, the Company recorded the warrants as a liability at their estimated fair value on the issuance date, which was $7.4 million, and changes in estimated fair value will be recorded as non-cash income or expense in the Company’s statement of operations at each subsequent period. At December 31, 2015, the fair value of the warrant liability was $10.6 million, which resulted in non-cash expense of $3.8 million in 2015. At December 31, 2014, the fair value of the warrant liability was $6.8 million, which resulted in non-cash income of $620,000 in 2014. In accordance with authoritative accounting guidance, the warrants were valued on the date of grant using the Black-Scholes valuation model. The assumptions used by the Company are summarized in the following table: Issuance December 31, December 31, Closing stock price $1.75 $1.46 $2.29 Expected dividends 0% 0% 0% Expected volatility 95% 90% 85% Risk free interest rate 1.39% 1.59% 1.49% Expected life of warrant 5 years 4.7 years 3.79 years The following table summarizes the estimated fair value of the warrant liability (in thousands) Balance at December 31, 2013 $ Warrants liability 7,376 Change in fair value of warrant liability (620 ) Balance at December 31, 2014 6,756 Change in fair value of warrant liability 3,811 Balance at December 31, 2015 $ 10,567 As of December 31, 2015, all of the warrants remained outstanding. On October 25, 2012, the Company entered into a Common Stock Purchase Agreement with certain accredited investors. As part of this agreement, the Company issued warrants to purchase 635,855 shares of common stock to the placement agent, or its permitted assigns. The warrants have an exercise price of $1.60 and a life of five years. The warrants vested immediately and expire October 25, 2017. Since these warrants were granted as part of an equity raise, the Company has treated them as a direct offering cost. The result of the transaction has no affect to equity. As of December 31, 2015, 311,834 warrants were outstanding. A summary of warrant activity for the Company for the years ended December 31, 2015, 2014 and 2013 is as follows: Number of Weighted Balance at December 31, 2012 1,632,501 $ 1.99 Granted $ Exercised $ Forfeited $ Balance at December 31, 2013 1,632,501 $ 1.99 Granted 7,029,808 $ 1.75 Exercised (232,619 ) $ 1.47 Forfeited (454,896 ) $ 1.88 Balance at December 31, 2014 7,974,794 $ 1.80 Granted $ Exercised (2,446 ) $ 1.60 Forfeited (63,449 ) $ 1.79 Balance at December 31, 2015 7,908,899 $ 1.79 There was no stock-based compensation expense included in general and administrative expenses relating to warrants issued to consultants for the years ended December 31, 2015, 2014 and 2013. A summary of all outstanding and exercisable warrants as of December 31, 2015 is as follows: Exercise Warrants Warrants Weighted $ 1.60 311,834 311,834 1.82 years $ 1.75 7,029,808 7,029,808 3.78 years $ 2.22 517,257 517,257 0.91 years $ 3.75 50,000 50,000 0.13 years $ 1.79 7,908,899 7,908,899 3.49 years |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | 5. Stockholders’ Equity Year Ended December 31, 2015 On August 29, 2015, the Company, SYN Biomics, a majority-owned subsidiary, and Mark Pimentel, M.D. entered into an amendment to the Stock Purchase Agreement dated December 3, 2013, which accelerated the date upon which Dr. Pimentel could exchange his shares of common stock in SYN Biomics for shares of the Company’s common stock. On August 29, 2015, Dr. Pimentel notified the Company of his intent to exchange all of the shares of common stock in SYN Biomics owned by him for 1,350,000 shares of the Company’s common stock in accordance with the terms of the Stock Purchase Agreement, as amended. On August 31, 2015, the Company issued 1,350,000 shares of the Company’s common stock to Dr. Pimentel in exchange for all of the shares of common stock of SYN Biomics held by Dr. Pimentel. On August 10, 2015, the Company expanded its relationship with Intrexon Corporation (“Intrexon”) and entered into an Exclusive Channel Collaboration Agreement with Intrexon that governs a “channel collaboration” arrangement in which the Company will use Intrexon’s technology relating to the development and commercialization of novel biotherapeutics for the treatment of patients with phenylketonuria (PKU). The Company paid Intrexon a technology access fee by the issuance of 937,500 shares of common stock, having a value equal to $3.0 million, which has been recorded as research and development expense. In July 2015, the Company completed a public offering of 15,333,333 shares of common stock, including the fully exercised over-allotment option by the underwriters covering 2.0 million shares, at an offering price of $3.00 per share. The total gross proceeds of the offering, including the exercise in full of the over-allotment option, were approximately $46.0 million. Net proceeds to the Company, after deducting the underwriters’ discount and other estimated expenses, were approximately $42.6 million. The Company paid direct offering costs of $3.4 million. In addition, during the year ended December 31, 2015, the Company issued 655,321 shares of common stock to Prev ABR LLC, with a fair value of $1,350,000, that was recorded as research and development expense, in consideration for achieving the first three milestones as set forth in the Asset Purchase Agreement dated November 28, 2012. In lieu of receiving any cash payment for achieving the first three milestones, Prev ABR LLC exercised its option to receive the milestone payments in shares of the Company’s common stock. The number of shares of common stock issued upon achievement of each milestone was based upon the average of the opening and closing prices of the Company’s stock on the date each milestone was achieved as specified in the Asset Purchase Agreement. Also, during the year ended December 31, 2015, the Company issued 35,008 shares of common stock, in connection with the exercise of stock options and warrants, for proceeds of approximately $41,000. Year Ended December 31, 2014 On October 10, 2014, the Company completed a registered direct offering of 14,059,616 units, with each unit consisting of one share of the Company’s common stock at a closing price of $1.47 for gross proceeds of $20.7 million and net proceeds of $19.1 million. The Company paid direct offering costs of $1.6 million. During the year ended December 31, 2014, the Company issued 6,583 shares of common stock, in connection with the exercise of stock options, for proceeds of approximately $4,000. The Company also issued 232,619 shares of common stock, in connection with cashless warrant exercises for the year ended December 31, 2014. Year Ended December 31, 2013 On December 11, 2013, the Company completed a firm commitment underwritten public offering of 13,225,000 shares of the Company’s common stock at a closing price of $1.00 for gross proceeds of $13.2 million. The Company paid direct offering costs of $1.0 million. During the year ended December 31, 2013, the Company issued 291,667 shares of common stock, in connection with the exercise of stock options, for proceeds of approximately $231,000. The Company also issued 334,911 shares of common stock in consideration for entering into worldwide exclusive license and option agreements with Cedars-Sinai Medical Center (“CSMC”), having a fair value of $425,000 ($1.27 per share), based on the average of prior 10 days quoted closing trading price. |
Non-controlling Interest
Non-controlling Interest | 12 Months Ended |
Dec. 31, 2015 | |
Noncontrolling Interest [Abstract] | |
Noncontrolling Interest Disclosure [Text Block] | 6. Non-controlling Interest On August 29, 2015, the Company, SYN Biomics and Mark Pimentel, M.D. entered into an amendment to the Pimentel Stock Purchase Agreement dated December 3, 2013, which accelerated the date upon which Dr. Pimentel could exchange his shares of common stock in SYN Biomics for shares of the Company’s common stock. On August 29, 2015, Dr. Pimentel notified the Company of his intent to exchange all of the shares of common stock in SYN Biomics, 8.5%, owned by him for 1,350,000 shares of the Company’s common stock in accordance with the terms of the Stock Purchase Agreement, as amended. On August 31, 2015, the Company issued 1,350,000 shares of the Company’s common stock to Dr. Pimentel in exchange for all of the shares of common stock of SYN Biomics held by Dr. Pimentel. The Company’s non-controlling interest is accounted for under ASC 810, Consolidation |
License, Collaborative and Empl
License, Collaborative and Employment Agreements and Commitments | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of License Collaborative and Employment Agreements and Commitments [Abstract] | |
License Collaborative And Employment Agreements And Commitments [Text Block] | 7. License, Collaborative and Employment Agreements and Commitments License and Collaborative Agreements As described below, the Company has entered into several license and collaborative agreements for the right to use research, technology and patents. Some of these license and collaborative agreements may contain milestones. The specific timing of such milestones cannot be predicted and are dependent on future developments as well as regulatory actions which cannot be predicted with certainty (including actions which may never occur). Further, under the terms of certain licensing agreements, the Company may have the obligation to pay certain milestones contingent upon the achievement of specific levels of sales. Due to the long-range nature of such commercial milestone amounts, they are neither probable at this time nor predictable and consequently are not included in this disclosure. Cedars-Sinai Medical Center (“CSMC”) Agreement On December 5, 2013, the Company, through its newly formed, majority owned subsidiary, SYN Biomics entered into a worldwide exclusive License Agreement with CSMC for the development of new treatment approaches to target non-bacterial intestinal microorganism life forms known as archaea that are associated with intestinal methane production and chronic diseases such as irritable bowel syndrome (IBS), obesity and type 2 diabetes. As part of the terms of the License Agreement the Company issued 334,911 unregistered shares of Company common stock to CSMC, paid $150,000 for the initial license fee and $220,000 for patent reimbursement fees. The License Agreement also provides that commencing on the second anniversary of the License Agreement, SYN Biomics will pay an annual maintenance fee, which payment shall be creditable against annual royalty payments owed under the License Agreement. In addition to royalty payments which are a percentage of Net Sales of licensed and technology products, SYN Biomics is obligated to pay CMSC a percentage of any non-royalty sublicense revenues, as well as additional consideration upon the achievement of milestones (the first two of which are payable in cash or unregistered shares of Company stock at the Company’s option). On December 5, 2013, the Company also entered into an option agreement with CSMC, which expired unexercised on December 31, 2014. The License Agreement terminates: (i) automatically if SYN Biomics enters into a liquidating bankruptcy or other specified bankruptcy event or if the performance of any term, covenant, condition or provision of the License Agreement will jeopardize the licensure of CMSC, its participation in certain reimbursement programs, its full accreditation by the Joint Commission of Accreditation of Healthcare Organizations or any similar state organizations, its tax exempt status or is deemed illegal; (ii) upon 30 days notice from CMSC if SYN Biomics fails to make a payment or use commercially reasonable efforts to exploit the patent rights; (iii) upon 60 days notice from CMSC if SYN Biomics fails to cure any breach or default of any material obligations under the License Agreement; or (iv) upon 90 days notice from SYN Biomics if CMCS fails to cure any breach or default of any material obligations under the License Agreement. SYN Biomics also has the right to terminate the License Agreement without cause upon six months notice to CSMC; however, upon such termination, SYN Biomics is obligated to pay a termination fee with the amount of such fee reduced: (i) if such termination occurs after an Investigational New Drug submission to the FDA but prior to completion of a Phase 2 clinical trial, (ii) reduced further if such termination occurs after completion of Phase 2 clinical trial but prior to completion of a Phase 3 clinical trial; and (iii) reduced to zero if such termination occurs after completion of a Phase 3 clinical trial. Prior to the execution of the CSMC License Agreement, SYN Biomics issued shares of common stock of SYN Biomics to each of CSMC and Mark Pimentel, M.D. (the primary inventor of the intellectual property), representing 11.5% and 8.5%, respectively, of the outstanding shares of SYN Biomics (the “SYN Biomics Shares”). The Stock Purchase Agreements for the SYN Biomics Shares provide for certain anti-dilution protection until such time as an aggregate of $3.0 million in proceeds from equity financings are received by SYN Biomics as well as a right, under certain circumstances in the event that the SYN Biomics Shares are not then freely tradable, and subject to NYSE MKT, LLC approval, as of the 18 and 36 month anniversary date of the effective date of the Stock Purchase Agreements, for each of CSMC and the Dr. Pimentel to exchange up to 50% of their SYN Biomics shares for unregistered share of the Company’s common stock, with the rate of exchange based upon the relative contribution of the valuation of SYN Biomics to the public market valuation of us at the time of each exchange. The Stock Purchase Agreements also provide for tag-along rights in the event of the sale by the Company of its shares of SYN Biomics. On August 29, 2015, the Company, SYN Biomics and Mark Pimentel, M.D. entered into an amendment to the Pimentel Stock Purchase Agreement, which accelerated the date upon which Dr. Pimentel can exchange his shares of common stock in SYN Biomics for shares of the Company’s common stock. On August 29, 2015, Dr. Pimentel notified the Company of his intent to exchange all of the shares of common stock in SYN Biomics owned by him for 1,350,000 shares of the Company’s common stock in accordance with the terms of the Pimentel Stock Purchase Agreement, as amended. On August 31, 2015, the Company issued 1,350,000 shares of the Company’s common stock to Dr. Pimentel in exchange for all of the shares of common stock of SYN Biomics held by Dr. Pimentel. University of Texas Austin Agreement On December 19, 2012, the Company entered into a License Agreement with The University of Texas at Austin (the “University”) for the exclusive license of the right to use, develop, manufacture, market and commercialize certain research and patents related to pertussis antibodies. The License Agreement provides that the University is entitled to payment of past patent expenses, an annual payment of $50,000 per year commencing on the effective date through December 31, 2014 and a $25,000 payment on December 31, 2015 and milestone payments of $50,000 upon commencement of Phase 1 clinical trials, $100,000 upon commencement of Phase 3 clinical trials, $250,000 upon NDA submission in the U.S., $100,000 upon European Medicines Agency approval and $100,000 upon regulatory approval in an Asian country. In addition, the University is entitled to a running royalty upon net sales. The License Agreement terminates upon the expiration of the patent rights; provided, however that the License Agreement is subject to early termination by the Company in its discretion and by the University for a breach of the License Agreement by the Company. In connection with the License Agreement, the Company and the University also entered into a Sponsored Research Agreement pursuant to which the University will perform certain research work related to pertussis. The Sponsored Research Agreement may be renewed annually, in the sole discretion of the Company, after the first year for two additional one year terms with a fixed fee for the first year of $303,287. The Sponsored Research Agreement was renewed for the second and third years for a fixed fee of $316,438 and $328,758 respectively, all payable in quarterly installments. The Sponsored Research Agreement was to expire on December 31, 2015; provided, however, the Sponsored Research Agreement is subject to early termination upon the written agreement of the parties, a default in the material obligations under the Research Agreement which remain uncured for sixty days after receipt of notice, automatically upon the Company’s bankruptcy or insolvency and by the Company in its sole discretion at any time after the one year anniversary of the date of execution thereof upon no less than 90 days notice. On October 22, 2015, the Company and the University amended the Sponsored Research Agreement to extend the termination date to January 15, 2017. All other terms and conditions of the Sponsored Research Agreement remain unchanged. No further or additional payments will be made to the University as a result of this amendment. Prev ABR LLC (“Prev”) Agreement On November 28, 2012, the Company entered into an agreement (“Prev Agreement”) to acquire the C. diff program assets of Prev, including pre-Investigational New Drug (IND) package, Phase 1 and Phase 2 clinical data, manufacturing process data and all issued and pending U.S. and international patents. Upon execution and closing of the Prev Agreement, the Company paid Prev cash payments of $235,000 and issued 625,000 unregistered shares of its common stock to Prev. As set forth in the Prev Agreement, Prev may be entitled to receive additional consideration upon the achievement of certain milestones including: (i) commencement of an IND; (ii) commencement of a Phase 1 clinical trial; (iii) commencement of a Phase 2 clinical trial; (iv) commencement of a Phase 3 clinical trial; (v) filing a Biologic License Application (BLA) in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement); and (vi) approval of a BLA in the U.S. and for territories outside the-U.S. With exception of the first milestone payment, the remaining milestones are payable 50% in cash and 50% in our stock, however, at Prev’s option the entire milestone may be payable in shares of our stock. Under the Prev Agreement, the Company may be required to the return all of assets acquired from Prev if on or prior to the Prev Agreement execution date (i) the Company has not initiated toxicology studies in non-rodent models within 30 months, or (ii) within 36 months the Company has not filed a C. Diff program IND and such failure is not due to action or inaction of Prev or breach of its representations or warranties or covenants or if there is a change of control as defined in the Prev Agreement and after such change of control the assets are not further developed; provided however that such 30 and 36 month periods can be extended by the Company for an additional 12 months upon payment of a cash milestone payment. As of December 31, 2015, the first three milestones have been met, and at Prev’s option, Prev elected to receive 655,321 shares of the Company’s common stock. Intrexon Exclusive Channel Collaboration On August 6, 2012, the Company expanded its relationship with Intrexon and entered into an Exclusive Channel Collaboration (“ECC”) (“Infectious Disease ECC”) with Intrexon that governs an “exclusive channel collaboration” arrangement in which the Company will use Intrexon’s technology relating to the identification, design and production of human antibodies and DNA vectors for the development and commercialization of a series of monoclonal antibody therapies for the treatment of certain serious infectious diseases. Pursuant to the terms of the Second Stock Issuance Agreement with Intrexon, which was approved by the Company’s stockholders on October 5, 2012, the Company issued 3,552,210 shares of its common stock, $0.001 par value, which issuance is also deemed paid in consideration for the execution and delivery of the Infectious Disease ECC, dated August 6, 2012, between the Company and Intrexon. The fair value of this transaction was $7.8 million and was charged to research and development expense for the year ended December 31, 2012, in accordance with the Company’s accounting policy. In connection with the transactions contemplated by the Second Stock Issuance Agreement, and pursuant to the First Amendment to Registration Rights Agreement (the “First Amendment to Registration Rights Agreement”) executed and delivered by the parties at the closing, which was declared effective on May 5, 2013. The Company filed a “resale” registration statement registering the resale of the shares issued under the Second Stock Issuance Agreement. Subject to certain expense allocations and other offsets provided in the Infectious Disease ECC, the Company will pay Intrexon royalties on annual net sales of the Synthetic Products, calculated on a Synthetic Product-by-Synthetic Product basis. The Company has likewise agreed to pay Intrexon a percentage of quarterly revenue obtained from a sublicensor in the event of a sublicensing arrangement. No such payments were made during the year ended December 31, 2015. The Company also agreed upon the filing of an IND application with the FDA for a Synthetic Product, or alternatively the filing of the first equivalent regulatory filing with a foreign regulatory agency (both as applicable, the “IND Milestone Event”), to pay Intrexon either (i) $2.0 million in cash, or (ii) that number of shares of Common Stock (the “IND Milestone Shares”) having a fair market value equaling $2.0 million where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the IND Milestone Event. Upon the first to occur of either first commercial sale of a Synthetic Product in a country or the granting of the regulatory approval of that Synthetic Product (both as applicable, the “Approval Milestone Event”), the Company agreed to pay to Intrexon either (i) $3.0 million in cash, or (ii) that number of shares of Common Stock (the “Approval Milestone Shares”) having a fair market value equaling $3.0 million where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the Approval Milestone Event. The Company also agreed that it will pay an optional and varying fee whereby the Company remits a payment, in cash or equity at our sole discretion, to Intrexon calculated as a multiple of the number of targets in excess of three total that the Company desires to elect (the “Field Expansion Fee”). The Field Expansion Fee must be paid completely in either Common Stock or cash, and will comprise either (i) $2.0 million in cash for each target in excess of three total that the Company elects, or (ii) that number of shares of Common Stock (the “Field Expansion Fee Shares”) having a fair market value equaling $2.0 million for each such target that the Company elects in excess of three where such fair market value is determined using published market data establishing the volume-weighted average price for a share of Common Stock over the 30 day period immediately preceding the date of the Field Expansion Fee Closing. No milestones were achieved or such payments were made during the year ended December 31, 2015. On August 10, 2015, the Company expanded our relationship with Intrexon and entered into an Exclusive Channel Collaboration Agreement (the “Channel Agreement”) with Intrexon that governs a “channel collaboration” arrangement in which the Company will use Intrexon’s technology relating to the development and commercialization of novel biotherapeutics (a “Collaboration Product”) for the treatment of patients with PKU. On September 2, 2015, in accordance with the terms of the Intrexon Stock Issuance Agreement that that the Company entered into in connection with the Channel Agreement, the Company paid Intrexon a technology access fee by the issuance of 937,500 shares of common stock, having a value equal to $3 million as of August 7, 2015. In addition, upon the achievement of certain milestones, the Company agreed to pay Intrexon milestone payments of up to $27 million for each product developed as follows: (i) $2 million upon first dosing of a patient in a Phase 1 clinical trial upon commencement of an IND, payable in stock or cash at our option; (ii) a payment 30 days after achievement of the first commercial sale of a Collaboration Product in the United States or approval of a New Drug Application and/or Biologics License Application for a Collaboration Product by the U.S. Food and Drug Administration; and (iii) a payment 30 days after achievement of the first commercial sale of a Collaboration Product in a nation subject to the authority of the European Medicines Agency (EMA) or approval of a Marketing Authorization Application for a Collaboration Product by the EMA. The Company will pay Intrexon royalties on annual net sales of Collaboration Products, calculated on a product-by-product basis, equal to a percent of net sales (ranging from mid-single digits on the first $100 million of net sales to mid-teen digits on net sales in excess of $750 million). The Company likewise agreed to pay Intrexon a percentage of quarterly revenue obtained from a sublicensor in the event of a sublicensing arrangement. Pursuant to the Second Amendment to Registration Rights Agreement, the Company filed a “resale” registration statement to register the shares issued under the Intrexon Stock Issuance Agreement, which was declared effective by the SEC on October 15, 2015. During December 2012, the Company paid Intrexon a prepayment of research and development expenses of $2.5 million for research and development goods and services to be provided in the future and has been recorded on the Company’s consolidated balance sheets in prepaid expenses and other current assets. Related research and development expenses of $424,000, $293,000 and $1.0 million were recorded against this prepayment for the years ended December 31, 2015, 2014 and 2013, respectively. At December 31, 2015, the Intrexon prepayment of research and development expenses was $643,000. Employment Agreements Effective February 3, 2012, Jeffrey Riley was appointed to serve as the Company’s Chief Executive Officer and President. In connection with his appointment, Mr. Riley entered into a three-year employment agreement with the Company (the “Original Riley Agreement”). Pursuant to the Original Riley Employment Agreement, Mr. Riley was entitled to an annual base salary of $348,000 and was eligible for discretionary performance and transactional bonus payments. Additionally, Mr. Riley was granted options to purchase 750,000 shares of the Company’s common stock with an exercise price equal to the per share market price on the date of issue. These options will vest pro rata, on a monthly basis, over 36 months. The Company measured the fair value of the stock options at approximately $1.7 million using a Black-Scholes valuation model. Effective March 18, 2015, the Company entered into a new two-year employment agreement with Mr. Riley (the “Riley Employment Agreement”). Pursuant to the new Riley Employment Agreement Mr. Riley’s annual base salary remained at $385,000. Beginning in 2015 and for each full calendar year thereafter, Mr. Riley will be eligible for an annual performance bonus of up to seventy-five percent (75%) of his base salary. The annual bonus will be based upon the Board’s assessment of Mr. Riley’s performance. The Employment Agreement also includes confidentiality obligations, inventions assignments by Mr. Riley as well as change in control, non-solicitation and non-competition provisions. Effective December 4, 2015, the Company entered into an amendment to the Riley Employment Agreement dated March 18, 2015, to increase Mr. Riley’s annual base salary to $550,000. On April 28, 2015, the Company entered into a two-year employment agreement with Steven A. Shallcross (the “Shallcross Employment Agreement”), who was appointed to serve as the Company’s Chief Financial Officer, Treasurer and Secretary, effective June 1, 2015. Pursuant to the Employment agreement, Mr. Shallcross is entitled to an annual base salary of $315,000. Additionally, Mr. Shallcross was granted options to purchase 900,000 shares of the Company’s common stock with an exercise price equal to the per share market price on the date of issue. These options vest pro rata, on a monthly basis, over 36 months. The Company measured the fair value of the stock options at approximately $1.9 million using a Black-Scholes valuation model. In 2015 and for each full calendar year thereafter, Mr. Shallcross will be eligible for an annual performance bonus of up to seventy-five percent (75%) of his base salary. The annual bonus is to be based upon the Board’s assessment of Mr. Shallcross’ performance. The Employment Agreement also includes confidentiality obligations and inventions assignments by Mr. Shallcross and non-solicitation and non-competition provisions. The Riley Employment Agreement and the Shallcross Employment Agreement each have a stated term of two years but may be terminated earlier pursuant to their terms. If either Mr. Riley’s or Mr. Shallcross’ (each an “Executive”) employment is terminated for any reason, he or his estate as the case may be, will be entitled to receive the accrued base salary, vacation pay, expense reimbursement and any other entitlements accrued by him to the extent not previously paid (the “Accrued Obligations”); provided however The Riley Employment Agreement and the Shallcross Employment Agreement each provide that upon the closing of a “Change in Control” (as defined below), the time period that the Executive will have to exercise all vested stock options and other awards that the Executive may have will be equal to the shorter of: (i) six (6) months after termination, or (ii) the remaining term of the award(s). Upon the closing of a Change in Control, all of Mr. Shallcross’ unvested options shall immediately vest. If within one year after the occurrence of a Change in Control, the Executive terminates his employment for “Good Reason” or the Company terminates the Executive’s employment for any reason other than death, Disability or Cause, the Executive will be entitled to receive: (i) the portion of his base salary for periods prior to the effective date of termination accrued but unpaid (if any); (ii) all unreimbursed expenses (if any); (iii) an aggregate amount (the “Change in Control Severance Amount”) equal to two times the sum of the base salary plus an amount equal to the bonus that would be payable if the “target” level performance were achieved under the Company’s annual bonus plan (if any) in respect of the fiscal year during which the termination occurs (or the prior fiscal year if bonus levels have not yet been established for the year of termination); and (iv) the payment or provision of any other benefits. The Change in Control Severance Amount is to be paid in a lump sum, if the Change in Control event constitutes a “change in the ownership” or a “change in the effective control” of the Company or a “change in the ownership of a substantial portion of a corporation’s assets” (each within the meaning of Section 409A of the Internal Revenue Code), or in 48 substantially equal payments, if the Change in Control event does not so comply with Section 409A. Upon the termination of employment for Good Reason by the Executive or upon the involuntary termination of employment of Executive for any reason other than death, Disability or Cause, in either case within two years commencing after the occurrence of a Change in Control, the Executive will be entitled to receive for a period of two years commencing on the date of such termination medical, dental, life and disability coverage for himself and his family members which is not less favorable than the coverage carried by the Company at the time of termination. For purpose of the Riley Employment Agreement and the Shallcross Employment Agreement, “Good Reason” is defined as the occurrence of any of the following events without the respective Executive’s consent: (i) a material reduction in the Executive’s base salary (other than an across-the-board decrease in base salary applicable to all executive officers of the Company); (ii) a material breach of the employment agreement by the Company; (iii) a material reduction in the Executive’s duties, authority and responsibilities relative to the Executive’s duties, authority, and responsibilities in effect immediately prior to such reduction; or (iv) the relocation of the Executive’s principal place of employment, without the Executive’s consent, in a manner that lengthens his one-way commute distance by fifty (50) or more miles from his then-current principal place of employment immediately prior to such relocation. For purposes of the Riley Employment Agreement and the Shallcross Employment Agreement, “Cause” is defined as that the Executive shall have engaged in any of the following acts or that any of the following events shall have occurred, all as determined by the Board of Directors of the Company in its sole and absolute discretion: (i) gross insubordination, acts of embezzlement or misappropriation of funds, fraud, dereliction of fiduciary obligations; (ii) conviction of a felony or other crime involving moral turpitude, dishonesty or theft (including entry of a nolo contendere Effective February 6, 2012, C. Evan Ballantyne was appointed the Company’s Chief Financial Officer. In connection with his appointment, Mr. Ballantyne entered into a three-year employment agreement with the Company, pursuant to which Mr. Ballantyne was entitled to an annual base salary of $298,000 and eligible for discretionary performance and transactional bonus payments. Additionally, Mr. Ballantyne was granted options to purchase 425,000 shares of our common stock with an exercise price equal to the Company’s per share market price on the date of issue. These options provided for vesting pro rata, on a monthly basis, over 36 months. The Company measured the fair value of the stock options at approximately $1 million using a Black-Scholes valuation model. On March 18, 2015, the Company entered into a new two-year employment agreement with C. Evan Ballantyne (the “Ballantyne Employment Agreement”). Pursuant to the new Ballantyne Employment Agreement, Mr. Ballantyne’s annual base salary remained at $335,000. Beginning in 2015 and for each full calendar year thereafter, Mr. Ballantyne was eligible for an annual performance bonus of up to seventy five percent (75%) of his base salary. The annual bonus was to be based upon the Board’s assessment of Mr. Ballantyne’s performance. The Employment Agreement also included confidentiality obligations and inventions assignments by Mr. Ballantyne as well as change in control, non-solicitation and non-competition provisions. Effective May 14, 2015, C. Evan Ballantyne, resigned his positions as Chief Financial Officer, Treasurer and Secretary. Pursuant to his resignation, the Company entered into a Severance Agreement effective May 14, 2015 (the “Severance Agreement”) with C. Evan Ballantyne. The Company agreed to pay Mr. Ballantyne as a severance payment his current base salary and continue to provide benefits at least equal to those which were provided at the time of termination for a period of twelve (12) months, as well as accrued and unpaid base salary and expense reimbursement. Mr. Ballantyne had the ability to exercise all stock options issued to him that vested prior to May 14, 2015 at any time prior to December 31, 2015. The Severance Agreement also contains additional provisions that are customary for agreements of this type. These include confidentiality and non-solicitation provisions. All costs associated with the Severance Agreement were recorded during the year ended December 31, 2015. Operating Lease During 2012, the Company entered into a twelve month operating lease for office space in Ann Arbor, Michigan. In September 2015, this lease was amended to extend the term of the lease to December 31, 2016, for annual lease payments of $40,000. In August 2015, the Company also entered into a sixty-six month operating lease that may be renewed for one additional term of five years, for office space in Rockville, Maryland, for annual lease payments of $142,172. The Company’s lease provides for fixed monthly rent for the term of the lease, with monthly rent increasing every 12 months subsequent to the first 12 months of the lease. During the years ended December 31, 2015, 2014 and 2013, the Company recognized rent expense of $108,000, $77,000 and $68,000, respectively. The following table summarizes the Company’s future minimum lease payments as of December 31, 2015 (in thousands) 2016 2017 2018 2019 2020 Total Operating Lease $ 148 $ 148 $ 152 $ 157 $ 162 $ 767 Total $ 148 $ 148 $ 152 $ 157 $ 162 $ 767 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | 8. Income Taxes There was no income tax expense for the years ended December 31, 2015 and 2014 due to the Company’s net losses. The Company’s tax expense differs from the “expected” tax expense for the years ended December 31, 2015 and 2014 (computed by applying the Federal Corporate tax rate of 34% to loss before taxes and 3.96% for blended state income tax rate, the blended rate used was 37.96%), as follows (in thousands): 2015 2014 Computed “expected” tax-benefit Federal $ (14,870 ) $ (6,727 ) Computed “expected” tax-benefit State (1,732 ) (783 ) Adjustment of “expected” tax-benefit to actual 199 (687 ) Meals, entertainment and other 8 13 Non-deductible stock-based compensation 877 789 Fair Market Value Adjustment Warrants 1,447 (235 ) Change in valuation allowance 14,071 7,630 $ $ The effects of temporary differences that gave rise to significant portions of deferred tax assets at December 31, 2015 and 2014 are as follows (in thousands): Deferred tax assets: 2015 2014 Stock issued for services $ 922 $ 585 Accrued compensation 105 Stock issued for acquisition of program 1,787 949 Stock issued for license agreement 2,308 2,507 Net operating loss carry-forward 37,852 24,657 Total gross deferred tax assets 42,974 28,698 Less: valuation allowance (42,974 ) (28,698 ) Total net deferred tax assets $ $ At December 31, 2015, the Company has a net operating loss carry-forward of approximately $99.4 million available to offset future taxable income expiring through 2035. However, utilization of these net operating losses may be limited due to potential ownership changes under Section 382 of the Internal Revenue Code. The valuation allowance at December 31, 2014 was approximately $28.7 million. The net change in valuation allowance during the year ended December 31, 2015 was an increase of approximately $14.1 million. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The ultimate realization of deferred income tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred income tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on consideration of these items, management has determined that enough uncertainty exists relative to the realization of the deferred income tax asset balances to warrant the application of a full valuation allowance as of December 31, 2015. ASC 740-10 “ Accounting for Uncertain Tax Positions As of December 31, 2015 and 2014, the Company had no unrecognized tax benefits and no adjustments to liabilities or operations were required under ASC 740-10. The Company’s practice was and continues to be to recognize interest and penalty expenses related to uncertain tax positions in income tax expense, which was zero for the years ended December 31, 2015 and 2014. The Company files United States federal and various state income tax returns. The Company is routinely subject to examinations by taxing authorities in these various jurisdictions. The Company’s U.S. tax matters for the years 2000 through 2014 remain subject to examination by the Internal Revenue Service due to the Company’s NOL carryforwards. The Company’s U. S. tax matters remain subject to examination by various state and local tax jurisdictions due to our NOL carryforwards. The Company does not anticipate that it is reasonably possible that unrecognized tax benefits as of December 31, 2015 will significantly change within the next 12 months. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions [Abstract] | |
Related Party Transactions Disclosure [Text Block] | 9. Related Party Transactions In August 2015, the Company expanded its relationship with Intrexon and entered into an Exclusive Channel Collaboration Agreement with Intrexon. In connection with the Channel Agreement, the Company paid Intrexon a technology access fee by the issuance of 937,500 shares of common stock, having a value equal to $3 million as of August 7, 2015. In August 2012, the Company entered into an Infectious Disease ECC with Intrexon and issued 3,552,210 shares of common stock as consideration, having a fair value of $7.8 million ($2.20 per share), based on the quoted closing trading price on October 5, 2012. In November 2011, the Company entered into its initial ECC with Intrexon and issued 3,123,558 shares of common stock as consideration, having a fair value of $1.7 million ($0.54 per share), based on the quoted closing trading price. In connection with the November 2011 and August 2012 ECCs, the Company paid Intrexon approximately $2.9 million during 2012, including a prepayment of research and development expenses of $2.5 million for research and development goods and services to be provided in the future which has been recorded on the Company’s balance sheet in prepaid expenses and other current assets as described in Note 3. In October 2012, the Company consummated its October 2012 Private Placement and entered into a stock purchase agreement with several investors, including NRM VII Holdings I, LLC, an entity affiliated with Intrexon. Randal J. Kirk, directly and through certain affiliates, has voting and dispositive power over a majority of the outstanding capital of Intrexon Corporation, and controls NRM VII Holdings I, LLC. Mr. Kirk disclaims beneficial ownership of the shares held by Intrexon Corporation and NRM VII Holdings I, LLC, except to the extent of any pecuniary interest therein. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information [Text Block] | 10. Selected Quarterly Financial Data (Unaudited) (In thousands, except per share amounts) Quarter Ended March 31, June 30, September 30, December 31, Loss from operations $ (8,207 ) $ (9,730 ) $ (11,650 ) $ (11,393 ) Net loss $ (12,359 ) $ (13,623 ) $ (7,507 ) $ (11,296 ) Net loss per share basic $ (0.17 ) $ (0.19 ) $ (0.08 ) $ (0.12 ) Net loss per share dilutive $ (0.17 ) $ (0.19 ) $ (0.12 ) $ (0.12 ) Weighted average common share basic 72,673,959 72,736,829 85,974,751 90,810,629 Weighted average common share dilutive 72,673,959 72,736,829 87,585,103 90,810,629 Quarter Ended March 31, June 30, September 30, December 31, Loss from operations $ (3,839 ) $ (4,651 ) $ (4,911 ) $ (7,101 ) Net loss $ (3,838 ) $ (4,556 ) $ (4,910 ) $ (6,480 ) Net loss per share basic and dilutive $ (0.07 ) $ (0.08 ) $ (0.08 ) $ (0.10 ) Weighted average common share basic and dilutive 58,324,260 58,543,528 58,543,528 65,483,336 |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation All inter-company transactions and accounts have been eliminated in consolidation. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Such estimates and assumptions impact, among others, the following: the estimated useful lives for property and equipment, fair value of warrants and stock options granted for services or compensation, respectively, estimates of the probability and potential magnitude of contingent liabilities, and the valuation allowance for deferred tax assets due to continuing and expected future operating losses. Making estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the date of the consolidated financial statements, which management considered in formulating its estimate could change in the near term due to one or more future confirming events. Accordingly, actual results could differ from those estimates. |
Noncontrolling Interest [Policy Text Block] | Non-controlling Interest The Company’s non-controlling interest represents the minority shareholder’s ownership interest related to the Company’s subsidiary, SYN Biomics. The Company reports its non-controlling interest in subsidiaries as a separate component of equity in the Consolidated Balance Sheets and reports both net loss attributable to the non-controlling interest and net loss attributable to the Company’s common shareholders on the face of the consolidated Statements of Operations. The Company’s equity interest in SYN Biomics is 88.5% and the non-controlling stockholder’s interest is 11.5%. This is reflected in the Consolidated Statements of Equity. |
Revenue Recognition, Policy [Policy Text Block] | Revenue Recognition The Company records revenue when all of the following have occurred: (1) persuasive evidence of an arrangement exists, (2) the service is completed without further obligation, (3) the sales price to the customer is fixed or determinable, and (4) collectability is reasonably assured. The Company recognizes milestone payments or upfront payments that have no contingencies as revenue when payment is received. For the years ended December 31, 2015, 2014 and December 31, 2013 the Company did not report any revenues. License Revenues The Company’s licensing agreements may contain multiple elements, such as non-refundable up-front fees, payments related to the achievement of particular milestones and royalties. Fees associated with substantive at risk performance-based milestones are recognized as revenue upon completion of the scientific or regulatory event specified in the agreement. When the Company has substantive continuing performance obligations under an arrangement, revenue is recognized over the performance period of the obligations using a time-based proportional performance approach. Under the time-based method, revenue is recognized over the arrangement’s estimated performance period based on the elapsed time compared to the total estimated performance period. Revenue recognized at any point in time is limited to the amount of non-contingent payments received or due. When the Company has no substantive continuing performance obligations under an arrangement, it recognizes revenue as the related fees become due. Revenues from royalties on third-party sales of licensed technologies are generally recognized in accordance with the contract terms when the royalties can be reliably determined and collectability is reasonably assured. To date, the Company has not received any royalty revenues. |
Risks And Uncertainties [Policy Text Block] | Risks and Uncertainties The Company’s operations could be subject to significant risks and uncertainties including financial, operational and regulatory risks and the potential risk of business failure. The global economic crisis has caused a general tightening in the credit markets, lower levels of liquidity, increases in the rates of default and bankruptcy, and extreme volatility in credit, equity and fixed income markets. These conditions may not only limit the Company’s access to capital, but also make it difficult for its customers, its vendors and its ability to accurately forecast and plan future business activities. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents Cash and cash equivalents include cash and highly liquid short-term investments with original maturities of three months or less. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment is recorded at cost and depreciated or amortized using the straight-line method over the estimated useful life of the asset or the underlying lease term for leasehold improvements, whichever is shorter. The estimated useful life by asset description is noted in the following table. Asset Description Estimated Useful Life Office equipment and furniture 3 5 years Manufacturing equipment 10 years Leasehold improvements and fixtures Lesser of estimated useful or life of lease Depreciation and amortization expense was approximately $72,000, $20,000 and $43,000 for the years ended December 31, 2015, 2014 and 2013, respectively. When assets are disposed of, the cost and accumulated depreciation are removed from the accounts. Repairs and maintenance are charged to expense as incurred. The Company reviews property and equipment for impairment to determine if assets are impaired due to obsolescence. As a result of this review, the Company recorded impairment losses of approximately $0, $0 and $121,000 for the years ended December 31, 2015, 2014 and 2013, respectively. |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such an event or change in circumstances occurs and potential impairment is indicated because the carrying values exceed the estimated future undiscounted cash flows of the asset, the Company will measure the impairment loss as the amount by which the carrying value of the asset exceeds its fair value. |
Earnings Per Share, Policy [Policy Text Block] | Net Income (Loss) per Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding including the effect of common share equivalents. Diluted net loss per share assumes the issuance of potential dilutive common shares outstanding for the period and adjusts for any changes in income and the repurchase of common shares that would have occurred from the assumed issuance, unless such effect is anti-dilutive. The number of options and warrants for the purchase of common stock that were excluded from the computations of net loss per common share for the year ended December 31, 2015 were 8,941,930 and 7,908,899, respectively, for the year ended December 31, 2014 were 5,981,106 and 7,974,794, respectively, and for the year ended December 31, 2013 were 3,909,580 and 1,632,501, respectively. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Costs The Company expenses research and development costs associated with developmental products not yet approved by the FDA to research and development expense as incurred. Research and development costs consist primarily of license fees (including upfront payments), milestone payments, manufacturing costs, salaries, stock-based compensation and related employee costs, fees paid to consultants and outside service providers for laboratory development, legal expenses resulting from intellectual property prosecution and other expenses relating to the design, development, testing and enhancement of our product candidates. Research and development expenses include external contract research organization (“CRO”) services. The Company makes payments to the CROs based on agreed upon terms and may include payments in advance of study services. The Company reviews and accrues CRO expenses based on services performed and rely on estimates of those costs applicable to the stage of completion of a study as provided by the CRO. Accrued CRO costs are subject to revisions as such studies progress to completion. The Company has accrued CRO expenses of $2.2 million and $525,000 that are included in accounts payable and accrued expenses at December 31, 2015 and 2014. The Company has prepaid CRO costs of $8.3 million and $0 at December 31, 2015 and 2014. |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments The fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows: • Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets; • Level 2 inputs: Inputs, other than quoted prices, included in Level 1 that are observable either directly or indirectly; and • Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions. In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy. The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, other current assets, accounts payable and accrued liabilities approximate fair value due to the relatively short period to maturity for these instruments. Cash and cash equivalents include money market accounts of $5.3 million and $13.6 million as of December 31, 2015 and December 31, 2014, respectively, that are measured using Level 1 inputs. The warrants issued in conjunction with the registered direct offering in October 2014 include a provision, that if the Company were to enter into certain transactions, as defined in the agreement, the warrants would be purchased from the holder at a premium. Accordingly, the Company recorded the warrants as liabilities at their fair value upon issuance and re-measures the fair value at each period end with the change in fair value recorded in the Statement of Operations. The Company uses the Black-Scholes options pricing model to estimate the fair value of the warrants. In using this model, the fair value is determined by applying Level 3 inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions. The assumptions used in calculating the estimated fair value of the warrants represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the warrant liability and the change in estimated fair value could be materially different. |
Stock Based Payment Arrangements [Policy Text Block] | Stock-Based Payment Arrangements Generally, all forms of stock-based payments, including stock option grants, warrants, restricted stock grants and stock appreciation rights are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model, based on the estimated number of awards that are ultimately expected to vest. Stock-based compensation awards issued to non-employees for services rendered are recorded at either the fair value of the services rendered or the fair value of the stock-based payment, whichever is more readily determinable and are re-measured over the corresponding vesting period. The expense resulting from stock-based payments is recorded in research and development expense or general and administrative expense in the consolidated statement of operations, depending on the nature of the services provided. |
Derivatives, Policy [Policy Text Block] | Derivative Instruments The warrants issued in conjunction with the registered direct offering in October 2014 include a provision, that if the Company were to enter into a certain transaction, as defined in the agreement, the warrants would be purchased from the holder at a premium. The reset provision of these warrants preclude equity accounting treatment under ASC 815. Accordingly, the Company is required to record the warrants as liabilities at their fair value upon issuance and re-measure the fair value at each period end with the change in fair value recorded in the Statement of Operations. When the warrants are exercised or cancelled, they are reclassified to equity. The Company uses the Black-Scholes options pricing model to estimate the fair value of the warrants. |
Income Tax, Policy [Policy Text Block] | Income Taxes The Company recognizes deferred tax liabilities and assets based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all deferred tax assets will not be realized. Management assesses the need to accrue or disclose uncertain tax positions for proposed potential adjustments from various federal and state authorities who regularly audit the Company in the normal course of business. In making these assessments, management must often analyze complex tax laws of multiple jurisdictions. The Company records the related interest expense and penalties, if any, as tax expense in the tax provision. At December 31, 2015 and 2014, respectively, the Company did not record any liabilities for uncertain tax positions. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements and Developments In November 2015, the FASB issued Accounting Standards Update (“ASU”) 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes, simplifying the balance sheet classification of deferred taxes by requiring all deferred taxes, along with any related valuation allowance, to be presented as noncurrent. This ASU is effective for the Company beginning in the first quarter of 2017, allows for early adoption and may be applied either prospectively or retrospectively. This ASU is not expected to have a material impact on the Company’s Consolidated Financial Statements. In January 2016, the FASB issued ASU No. 2016-01, “Financial Instruments Overall: Recognition and Measurement of Financial Assets and Financial Liabilities” (“ASU 2016-01”). The guidance affects the accounting for equity investments, financial liabilities under the fair value option and the presentation and disclosure requirements of financial instruments. The guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company is evaluating the effect that ASU 2016-01 will have on its consolidated financial statements and related disclosures. In February of 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)” (“ASU 2016-02”). Under ASU 2016-02, an entity will be required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. ASU 2016-02 offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. For public companies, ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period, and requires a modified retrospective adoption, with early adoption permitted. We are in the process of evaluating the future impact of ASU 2016-02 on our consolidated financial position, results of operations and cash flows. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Estimated Useful Life Of Asset [Table Text Block] | The estimated useful life by asset description is noted in the following table. Asset Description Estimated Useful Life Office equipment and furniture 3 5 Manufacturing equipment 10 Leasehold improvements and fixtures Lesser of estimated useful or life of lease |
Selected Balance Sheet Inform20
Selected Balance Sheet Information (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Other Current Assets [Table Text Block] | Prepaid expenses and other current assets (in thousands): December 31, 2015 2014 Intrexon prepaid research and development expenses See Note 7 $ 643 $ 1,067 Prepaid clinical research organization expenses 8,329 Prepaid insurances 339 228 Other prepaid expenses 208 253 Total $ 9,519 $ 1,548 |
Property, Plant and Equipment [Table Text Block] | Property and equipment (in thousands): December 31, 2015 2014 Computer and office equipment $ 346 $ 93 Software 11 11 Leasehold improvements 242 599 104 Less accumulated depreciation and amortization (105 ) (39 ) Total $ 494 $ 65 |
Accrued Expenses [Table Text Block] | Accrued expenses (in thousands): December 31, 2015 2014 Accrued manufacturing costs $ $ 247 Accrued vendor payments 133 176 Accrued milestones payments 350 Accrued clinical consulting services 164 525 Total $ 297 $ 1,298 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-based Compensation Arrangement by Share-based Payment Award Options and Warrants Vested and Expected to Vest Outstanding and Exercisable [Table Text Block] | The Black-Scholes assumptions used in the years ended December 31, 2015, 2014 and 2013 are as follows: Year ended December 31, 2015 2014 2013 Exercise price $ 1.54 $2.76 $ 1.46 $2.91 $ 1.64 $1.74 Expected dividends 0% 0% 0% Expected volatility 88% 131% 101% 150% 141% 154% Risk free interest rate 1.32% 2.19% 1.57% 2.73% 0.77% 2.54% Expected life of option 5 years 10 years 5 years 10 years 5 years 10 years |
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | Options Weighted Weighted Aggregate Balance December 31, 2012 4,453,746 $ 1.78 6.43 years $ 1,308,000 Granted 222,500 $ 1.69 Exercised (291,666 ) $ 0.79 $ 71,000 Forfeited (475,000 ) $ 2.30 Balance December 31, 2013 3,909,580 $ 1.78 5.59 years $ 785,000 Granted 2,382,500 $ 2.36 Exercised (6,583 ) $ 0.58 $ 8,000 Forfeited (304,391 ) $ 1.93 Balance December 31, 2014 5,981,106 $ 2.01 5.80 years $ 685,000 Granted 3,781,666 $ 2.37 Exercised (35,008 ) $ 1.16 $ 44,000 Expired (483,332 ) $ 2.48 Forfeited (302,502 ) $ 1.91 Balance December 31, 2015 outstanding 8,941,930 $ 2.14 5.67 years $ 2,900,000 Balance December 31, 2015 exercisable 4,757,754 $ 1.92 4.54 years $ 2,272,000 Grant date fair value of options granted 2015 $ 7,974,000 Weighted average grant date fair value 2015 $ 2.12 Grant date fair value of options granted 2014 $ 4,974,000 Weighted average grant date fair value 2014 $ 2.09 Grant date fair value of options granted 2013 $ 350,000 Weighted average grant date fair value 2013 $ 1.57 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding and Exercisable [Table Text Block] | The options outstanding and exercisable at December 31, 2015 are as follows: Options Outstanding Options Exercisable Range of Options Weighted Weighted Options Weighted Weighted $ 0.09 $2.00 3,029,938 $ 1.40 4.12 years 2,363,683 $ 1.34 3.38 years $ 2.01 $3.00 5,866,168 2.50 6.50 years 2,348,247 2.44 5.76 years $ 3.01 $6.00 45,824 5.24 1.62 years 45,824 5.24 1.62 years $ 0.09 $6.00 8,941,930 $ 2.14 5.67 years 4,757,754 $ 1.92 4.54 years The options outstanding and exercisable at December 31, 2014 are as follows: Options Outstanding Options Exercisable Range of Options Weighted Weighted Options Weighted Weighted $ 0.09 $2.00 2,703,280 $ 1.37 4.33 years 2,018,074 $ 1.28 3.73 years $ 2.01 $3.00 3,232,002 2.49 7.08 years 1,829,298 2.40 6.73 years $ 3.01 $6.00 45,824 5.24 2.62 years 45,824 5.24 2.62 years $ 0.09 $6.00 5,981,106 $ 2.01 5.80 years 3,893,196 $ 1.85 5.12 years The options outstanding and exercisable at December 31, 2013 are as follows: Options Outstanding Options Exercisable Range of Options Weighted Weighted Options Weighted Weighted $ 0.09 $2.00 2,093,196 $ 1.29 4.73 years 1,901,737 $ 1.25 4.64 years $ 2.01 $3.00 1,770,560 2.28 6.65 years 1,205,976 2.26 6.25 years $ 3.01 $6.00 45,824 5.24 3.62 years 45,824 5.24 3.62 years $ 0.09 $6.00 3,909,580 $ 1.78 5.59 years 3,153,537 $ 1.69 5.24 years |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Non Vested and Expected to Vest Exercisable [Table Text Block] | The following is a summary of the Company’s non-vested stock options at December 31, 2015: Unvested Weighted Balance December 31, 2012 1,561,869 $ 2.11 Granted 222,500 $ 1.57 Vested/Exercised (883,882 ) $ 1.93 Forfeited/Cancelled (144,444 ) $ 2.27 Balance December 31, 2013 756,043 $ 2.17 Granted 2,382,500 $ 2.09 Vested/Exercised (1,050,633 ) $ 2.35 Balance December 31, 2014 2,087,910 $ 2.30 Granted 3,781,666 $ 2.12 Vested/Exercised (1,382,898 ) $ 2.02 Forfeited/Cancelled (302,502 ) $ 1.92 Non-vested December 31, 2015 4,184,176 $ 1.97 Weighted average remaining period for vesting 2.36 years |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Table Text Block] | The assumptions used by the Company are summarized in the following table: Issuance December 31, December 31, Closing stock price $1.75 $1.46 $2.29 Expected dividends 0% 0% 0% Expected volatility 95% 90% 85% Risk free interest rate 1.39% 1.59% 1.49% Expected life of warrant 5 years 4.7 years 3.79 years |
Schedule Of Estimated Fair Value Of The Warrant Liability [Table Text Block] | The following table summarizes the estimated fair value of the warrant liability (in thousands) Balance at December 31, 2013 $ Warrants liability 7,376 Change in fair value of warrant liability (620 ) Balance at December 31, 2014 6,756 Change in fair value of warrant liability 3,811 Balance at December 31, 2015 $ 10,567 |
Schedule of Warrant Activity [Table Text Block] | A summary of warrant activity for the Company for the years ended December 31, 2015, 2014 and 2013 is as follows: Number of Weighted Balance at December 31, 2012 1,632,501 $ 1.99 Granted $ Exercised $ Forfeited $ Balance at December 31, 2013 1,632,501 $ 1.99 Granted 7,029,808 $ 1.75 Exercised (232,619 ) $ 1.47 Forfeited (454,896 ) $ 1.88 Balance at December 31, 2014 7,974,794 $ 1.80 Granted $ Exercised (2,446 ) $ 1.60 Forfeited (63,449 ) $ 1.79 Balance at December 31, 2015 7,908,899 $ 1.79 |
Schedule of Warrant Outstanding and Exercisable [Table Text Block] | A summary of all outstanding and exercisable warrants as of December 31, 2015 is as follows: Exercise Warrants Warrants Weighted $ 1.60 311,834 311,834 1.82 years $ 1.75 7,029,808 7,029,808 3.78 years $ 2.22 517,257 517,257 0.91 years $ 3.75 50,000 50,000 0.13 years $ 1.79 7,908,899 7,908,899 3.49 years |
License, Collaborative and Em22
License, Collaborative and Employment Agreements and Commitments (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of License Collaborative and Employment Agreements and Commitments [Abstract] | |
Due for License Agreements [Table Text Block] | The following table summarizes the Company’s future minimum lease payments as of December 31, 2015 (in thousands) 2016 2017 2018 2019 2020 Total Operating Lease $ 148 $ 148 $ 152 $ 157 $ 162 $ 767 Total $ 148 $ 148 $ 152 $ 157 $ 162 $ 767 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | There was no income tax expense for the years ended December 31, 2015 and 2014 due to the Company’s net losses. The Company’s tax expense differs from the “expected” tax expense for the years ended December 31, 2015 and 2014 (computed by applying the Federal Corporate tax rate of 34% to loss before taxes and 3.96% for blended state income tax rate, the blended rate used was 37.96%), as follows (in thousands): 2015 2014 Computed “expected” tax-benefit Federal $ (14,870 ) $ (6,727 ) Computed “expected” tax-benefit State (1,732 ) (783 ) Adjustment of “expected” tax-benefit to actual 199 (687 ) Meals, entertainment and other 8 13 Non-deductible stock-based compensation 877 789 Fair Market Value Adjustment Warrants 1,447 (235 ) Change in valuation allowance 14,071 7,630 $ $ |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | The effects of temporary differences that gave rise to significant portions of deferred tax assets at December 31, 2015 and 2014 are as follows (in thousands): Deferred tax assets: 2015 2014 Stock issued for services $ 922 $ 585 Accrued compensation 105 Stock issued for acquisition of program 1,787 949 Stock issued for license agreement 2,308 2,507 Net operating loss carry-forward 37,852 24,657 Total gross deferred tax assets 42,974 28,698 Less: valuation allowance (42,974 ) (28,698 ) Total net deferred tax assets $ $ |
Selected Quarterly Financial 24
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information [Table Text Block] | Quarter Ended March 31, June 30, September 30, December 31, Loss from operations $ (8,207 ) $ (9,730 ) $ (11,650 ) $ (11,393 ) Net loss $ (12,359 ) $ (13,623 ) $ (7,507 ) $ (11,296 ) Net loss per share basic $ (0.17 ) $ (0.19 ) $ (0.08 ) $ (0.12 ) Net loss per share dilutive $ (0.17 ) $ (0.19 ) $ (0.12 ) $ (0.12 ) Weighted average common share basic 72,673,959 72,736,829 85,974,751 90,810,629 Weighted average common share dilutive 72,673,959 72,736,829 87,585,103 90,810,629 Quarter Ended March 31, June 30, September 30, December 31, Loss from operations $ (3,839 ) $ (4,651 ) $ (4,911 ) $ (7,101 ) Net loss $ (3,838 ) $ (4,556 ) $ (4,910 ) $ (6,480 ) Net loss per share basic and dilutive $ (0.07 ) $ (0.08 ) $ (0.08 ) $ (0.10 ) Weighted average common share basic and dilutive 58,324,260 58,543,528 58,543,528 65,483,336 |
Organization and Nature of Op25
Organization and Nature of Operations and Basis of Presentation (Details Textual) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Organization and Nature of Operations and Basis of Presentation [Line Items] | ||||
Cash and Cash Equivalents, at Carrying Value, Total | $ 20,818 | $ 17,525 | $ 14,625 | $ 9,954 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies (Details) | 12 Months Ended |
Dec. 31, 2015 | |
Office Equipment And Furniture | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Office Equipment And Furniture | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Manufacturing Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 10 years |
Leasehold improvements and fixtures | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Estimated Useful Lives | Lesser of estimated useful or life of lease |
Summary of Significant Accoun27
Summary of Significant Accounting Policies (Details Textual) - USD ($) | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Summary of Significant Accounting Policies [Line Items] | ||||
Depreciation, Depletion and Amortization, Total | $ 72,000 | $ 20,000 | $ 43,000 | |
Goodwill, Impairment Loss | 0 | 0 | 121,000 | |
Cash and Cash Equivalents, at Carrying Value | $ 20,818,000 | 17,525,000 | $ 14,625,000 | $ 9,954,000 |
Equity Method Investment, Ownership Percentage | 88.50% | |||
Noncontrolling Interest, Ownership Percentage by Parent | 11.50% | |||
Accrued Liabilities | $ 2,200,000 | 525,000 | ||
Prepaid Expense | $ 8,300,000 | $ 0 | ||
Warrant [Member] | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 7,908,899 | 7,974,794 | 1,632,501 | |
Options [Member] | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 8,941,930 | 5,981,106 | 3,909,580 | |
Money Market Accounts [Member] | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Cash and Cash Equivalents, at Carrying Value | $ 5,300,000 | $ 13,600,000 |
Selected Balance Sheet Inform28
Selected Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Other Current Assets [Line Items] | ||
Intrexon prepaid research and development expenses | $ 643 | $ 1,067 |
Prepaid clinical research organization expenses | 8,329 | 0 |
Prepaid insurances | 339 | 228 |
Other prepaid expenses | 208 | 253 |
Total | $ 9,519 | $ 1,548 |
Selected Balance Sheet Inform29
Selected Balance Sheet Information (Details 1) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 599 | $ 104 |
Less accumulated depreciation and amortization | (105) | (39) |
Total | 494 | 65 |
Computer and office equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 346 | 93 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 11 | 11 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 242 | $ 0 |
Selected Balance Sheet Inform30
Selected Balance Sheet Information (Details 2) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Accrued Expenses [Line Items] | ||
Accrued manufacturing costs | $ 0 | $ 247 |
Accrued vendor payments | 133 | 176 |
Accrued milestones payments | 0 | 350 |
Accrued clinical consulting services | 164 | 525 |
Total | $ 297 | $ 1,298 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected dividends | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price | $ 1.54 | $ 1.46 | $ 1.64 |
Expected volatility | 88.00% | 101.00% | 141.00% |
Risk free interest rate | 1.32% | 1.57% | 0.77% |
Expected life of option | 5 years | 5 years | 5 years |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price | $ 2.76 | $ 2.91 | $ 1.74 |
Expected volatility | 131.00% | 150.00% | 154.00% |
Risk free interest rate | 2.19% | 2.73% | 2.54% |
Expected life of option | 10 years | 10 years | 10 years |
Stock-Based Compensation (Det32
Stock-Based Compensation (Details 1) - Stock Option [Member] - USD ($) | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, Beginning Balance | 5,981,106 | 3,909,580 | 4,453,746 | |
Options, Granted | 3,781,666 | 2,382,500 | 222,500 | |
Options, Exercised | (35,008) | (6,583) | (291,666) | |
Options, Expired | (483,332) | |||
Options, Forfeited | (302,502) | (304,391) | (475,000) | |
Options, Ending Balance | 8,941,930 | 5,981,106 | 3,909,580 | 4,453,746 |
Options, Exercisable | 4,757,754 | |||
Weighted Average Exercise Price, Beginning Balance | $ 2.01 | $ 1.78 | $ 1.78 | |
Weighted Average Exercise Price, Granted | 2.37 | 2.36 | 1.69 | |
Weighted Average Exercise Price, Exercised | 1.16 | 0.58 | 0.79 | |
Weighted Average Exercise Price, Expired | 2.48 | |||
Weighted Average Exercise Price, Forfeited | 1.91 | 1.93 | 2.3 | |
Weighted Average Exercise Price, Ending Balance | 2.14 | $ 2.01 | $ 1.78 | $ 1.78 |
Weighted Average Exercise Price, Exercisable | $ 1.92 | |||
Weighted Average Remaining Contractual Life, Balance Outstanding | 5 years 8 months 1 day | 5 years 9 months 18 days | 5 years 7 months 2 days | 6 years 5 months 5 days |
Weighted Average Remaining Contractual Life, Exercisable | 4 years 6 months 14 days | |||
Aggregate Intrinsic Value, Beginning Balance | $ 685,000 | $ 785,000 | $ 1,308,000 | |
Aggregate Intrinsic Value, Exercised | 44,000 | 8,000 | 71,000 | |
Aggregate Intrinsic Value, Ending Balance | 2,900,000 | 685,000 | 785,000 | $ 1,308,000 |
Aggregate Intrinsic Value, Exercisable | 2,272,000 | |||
Grant date fair value of options granted | $ 7,974,000 | $ 4,974,000 | $ 350,000 | |
Weighted average grant date fair value | $ 2.12 | $ 2.09 | $ 1.57 |
Stock-Based Compensation (Det33
Stock-Based Compensation (Details 2) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Range of Exercise Price 0.09-2.00 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options Outstanding, Range of Exercise Price Lower | $ 0.09 | $ 0.09 | $ 0.09 |
Options Outstanding, Range of Exercise Price Upper | $ 2 | $ 2 | $ 2 |
Options Outstanding, Options | 3,029,938 | 2,703,280 | 2,093,196 |
Options Outstanding, Weighted Average Exercise Price | $ 1.40 | $ 1.37 | $ 1.29 |
Options Outstanding, Weighted Average Remaining Contractual Life | 4 years 1 month 13 days | 4 years 3 months 29 days | 4 years 8 months 23 days |
Options Exercisable, Options | 2,363,683 | 2,018,074 | 1,901,737 |
Options Exercisable, Weighted Average Exercise Price | $ 1.34 | $ 1.28 | $ 1.25 |
Options Exercisable, Weighted Average Remaining Contractual Life | 3 years 4 months 17 days | 3 years 8 months 23 days | 4 years 7 months 20 days |
Range of Exercise Price 2.01-3.00 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options Outstanding, Range of Exercise Price Lower | $ 2.01 | $ 2.01 | $ 2.01 |
Options Outstanding, Range of Exercise Price Upper | $ 3 | $ 3 | $ 3 |
Options Outstanding, Options | 5,866,168 | 3,232,002 | 1,770,560 |
Options Outstanding, Weighted Average Exercise Price | $ 2.50 | $ 2.49 | $ 2.28 |
Options Outstanding, Weighted Average Remaining Contractual Life | 6 years 6 months | 7 years 29 days | 6 years 7 months 24 days |
Options Exercisable, Options | 2,348,247 | 1,829,298 | 1,205,976 |
Options Exercisable, Weighted Average Exercise Price | $ 2.44 | $ 2.40 | $ 2.26 |
Options Exercisable, Weighted Average Remaining Contractual Life | 5 years 9 months 4 days | 6 years 8 months 23 days | 6 years 3 months |
Range of Exercise Price 3.01-6.00 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options Outstanding, Range of Exercise Price Lower | $ 3.01 | $ 3.01 | $ 3.01 |
Options Outstanding, Range of Exercise Price Upper | $ 6 | $ 6 | $ 6 |
Options Outstanding, Options | 45,824 | 45,824 | 45,824 |
Options Outstanding, Weighted Average Exercise Price | $ 5.24 | $ 5.24 | $ 5.24 |
Options Outstanding, Weighted Average Remaining Contractual Life | 1 year 7 months 13 days | 2 years 7 months 13 days | 3 years 7 months 13 days |
Options Exercisable, Options | 45,824 | 45,824 | 45,824 |
Options Exercisable, Weighted Average Exercise Price | $ 5.24 | $ 5.24 | $ 5.24 |
Options Exercisable, Weighted Average Remaining Contractual Life | 1 year 7 months 13 days | 2 years 7 months 13 days | 3 years 7 months 13 days |
Range of Exercise Price 0.09-6.00 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options Outstanding, Range of Exercise Price Lower | $ 0.09 | $ 0.09 | $ 0.09 |
Options Outstanding, Range of Exercise Price Upper | $ 6 | $ 6 | $ 6 |
Options Outstanding, Options | 8,941,930 | 5,981,106 | 3,909,580 |
Options Outstanding, Weighted Average Exercise Price | $ 2.14 | $ 2.01 | $ 1.78 |
Options Outstanding, Weighted Average Remaining Contractual Life | 5 years 8 months 1 day | 5 years 9 months 18 days | 5 years 7 months 2 days |
Options Exercisable, Options | 4,757,754 | 3,893,196 | 3,153,537 |
Options Exercisable, Weighted Average Exercise Price | $ 1.92 | $ 1.85 | $ 1.69 |
Options Exercisable, Weighted Average Remaining Contractual Life | 4 years 6 months 14 days | 5 years 1 month 13 days | 5 years 2 months 26 days |
Stock-Based Compensation (Det34
Stock-Based Compensation (Details 3) - Stock Option [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock Options, Non-vested - Beginning Balance | 2,087,910 | 756,043 | 1,561,869 |
Stock Options, Granted | 3,781,666 | 2,382,500 | 222,500 |
Stock Options, Vested/Exercised | (1,382,898) | (1,050,633) | (883,882) |
Stock Options, Forfeited/Cancelled | (302,502) | (144,444) | |
Stock Options, Non-vested - Ending Balance | 4,184,176 | 2,087,910 | 756,043 |
Weighted Average Grant Date Fair Value, Non-vested - Beginning Balance | $ 2.30 | $ 2.17 | $ 2.11 |
Weighted Average Grant Date Fair Value, Granted | 2.12 | 2.09 | 1.57 |
Weighted Average Grant Date Fair Value, Vested/Exercised | 2.02 | 2.35 | 1.93 |
Weighted Average Grant Date Fair Value, Forfeited/Cancelled | 1.92 | 2.27 | |
Weighted Average Grant Date Fair Value, Non-vested - Ending Balance | $ 1.97 | $ 2.30 | $ 2.17 |
Stock Options, Weighted average remaining period for vesting | 2 years 4 months 10 days |
Stock-Based Compensation (Det35
Stock-Based Compensation (Details 4) - Stock Warrants [Member] - $ / shares | Oct. 10, 2014 | Dec. 31, 2015 | Dec. 31, 2014 |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Closing stock price | $ 1.75 | $ 2.29 | $ 1.46 |
Expected dividends | 0.00% | 0.00% | 0.00% |
Expected volatility | 95.00% | 85.00% | 90.00% |
Risk free interest rate | 1.39% | 1.49% | 1.59% |
Expected life of warrant | 5 years | 3 years 9 months 14 days | 4 years 8 months 12 days |
Stock-Based Compensation (Det36
Stock-Based Compensation (Details 5) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Beginning Balance | $ 6,756 | $ 0 | |
Warrants liability | 7,376 | ||
Change in fair value of warrant liability | 3,811 | (620) | $ 0 |
Ending Balance | $ 10,567 | $ 6,756 | $ 0 |
Stock-Based Compensation (Det37
Stock-Based Compensation (Details 6) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Warrants, Beginning Balance | 7,974,794 | 1,632,501 | 1,632,501 |
Number of Warrants, Granted | 0 | 7,029,808 | 0 |
Number of Warrants, Exercised | (2,446) | (232,619) | 0 |
Number of Warrants, Forfeited | (63,449) | (454,896) | 0 |
Number of Warrants, Ending Balance | 7,908,899 | 7,974,794 | 1,632,501 |
Weighted Average Exercise Price, Beginning Balance | $ 1.8 | $ 1.99 | $ 1.99 |
Weighted Average Exercise Price, Granted | 0 | 1.75 | 0 |
Weighted Average Exercise Price, Exercised | 1.6 | 1.47 | 0 |
Weighted Average Exercise Price, Forfeited | 1.79 | 1.88 | 0 |
Weighted Average Exercise Price, Ending Balance | $ 1.79 | $ 1.8 | $ 1.99 |
Stock-Based Compensation (Det38
Stock-Based Compensation (Details 7) | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Exercise Price 1.60 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 1.60 |
Warrants Outstanding | 311,834 |
Warrants Exercisable | 311,834 |
Weighted Average Remaining Contractual Life | 1 year 9 months 25 days |
Exercise Price 1.75 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 1.75 |
Warrants Outstanding | 7,029,808 |
Warrants Exercisable | 7,029,808 |
Weighted Average Remaining Contractual Life | 3 years 9 months 11 days |
Exercise Price 2.22 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 2.22 |
Warrants Outstanding | 517,257 |
Warrants Exercisable | 517,257 |
Weighted Average Remaining Contractual Life | 10 months 28 days |
Exercise Price 3.75 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 3.75 |
Warrants Outstanding | 50,000 |
Warrants Exercisable | 50,000 |
Weighted Average Remaining Contractual Life | 1 month 17 days |
Exercise Price 1.79 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise Price | $ / shares | $ 1.79 |
Warrants Outstanding | 7,908,899 |
Warrants Exercisable | 7,908,899 |
Weighted Average Remaining Contractual Life | 3 years 5 months 26 days |
Stock-Based Compensation (Det39
Stock-Based Compensation (Details Textual) - USD ($) | Oct. 10, 2014 | Oct. 25, 2012 | Mar. 20, 2007 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2001 | May. 15, 2015 | Oct. 22, 2013 | Nov. 02, 2010 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 8,300,000 | |||||||||
Employee Service Share-based Compensation, Cash Received from Exercise of Stock Options | 41,000 | $ 4,000 | $ 232,000 | |||||||
Proceeds from Issuance of Common Stock | 46,000,000 | 20,668,000 | 13,224,000 | |||||||
Change in fair value of warrant liabilities | 3,811,000 | (620,000) | 0 | |||||||
Warrant liabilities | $ 10,567,000 | $ 6,756,000 | $ 0 | |||||||
Class of Warrant or Right, Outstanding | 311,834 | |||||||||
Warrant [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Issuance of Warrants to Purchase of Common Stock | 635,855 | |||||||||
Warrants Exercise Price Per Share | $ 1.60 | |||||||||
Investment Warrants Expiration Date | Oct. 25, 2017 | |||||||||
Epitope [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock Options Expiration Term | Jun 30, 2018 | |||||||||
Employees And Directors [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 3,781,666 | 2,382,500 | 222,500 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Fair Value | $ 8,000,000 | $ 5,000,000 | $ 350,000 | |||||||
Employee [Member] | General and Administrative Expenses and Research and Development Expense [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Allocated Share-based Compensation Expense | 2,300,000 | 2,100,000 | 1,300,000 | |||||||
Consultant [Member] | General and Administrative Expenses and Research and Development Expense [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Allocated Share-based Compensation Expense | $ 888,000 | 380,000 | $ 324,000 | |||||||
2001 Stock Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 671,607 | |||||||||
2001 Stock Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 250,000 | |||||||||
2007 Stock Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 2,500,000 | 428,657 | ||||||||
2007 Stock Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 250,000 | |||||||||
2010 Stock Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 7,841,666 | 3,000,000 | ||||||||
2010 Stock Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 8,000,000 | 6,000,000 | ||||||||
2010 Stock Plan [Member] | Minimum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 6,000,000 | 3,000,000 | ||||||||
Stock Warrants [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Issuance of Warrants to Purchase of Common Stock | 0.5 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Warrants, Vested and Expected to Vest Outstanding, Number | 1.75 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 7,029,808 | |||||||||
Sale of Stock, Number of Shares Issued in Transaction | 14,059,616 | |||||||||
Sale of Stock, Price Per Share | $ 1.47 | |||||||||
Proceeds from Issuance of Common Stock | $ 19,100,000 | |||||||||
Change in fair value of warrant liabilities | $ 7,400,000 | $ 3,800,000 | 620,000 | |||||||
Warrant liabilities | $ 10,600,000 | $ 6,800,000 |
Stockholders' Equity (Details T
Stockholders' Equity (Details Textual) - USD ($) | Aug. 10, 2015 | Oct. 10, 2014 | Dec. 11, 2013 | Aug. 31, 2015 | Aug. 29, 2015 | Aug. 10, 2015 | Jul. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Stockholders Equity [Line Items] | ||||||||||
Proceeds from Stock Options Exercised | $ 4,000 | $ 231,000 | ||||||||
Stock Issued During Period, Value, New Issues | $ 42,643,000 | $ 11,647,000 | $ 12,193,000 | |||||||
Channel Collaboration Agreement [Member] | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Shares, Issued | 937,500 | 937,500 | ||||||||
Stock Issued | $ 3,000,000 | $ 3,000,000 | ||||||||
Stock Purchase Agreement [Member] | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Conversion of Stock, Shares Converted | 1,350,000 | |||||||||
Conversion of Stock, Shares Issued | 1,350,000 | 1,350,000 | ||||||||
Employee Stock Option [Member] | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Share-Based Compensation Arrangement By Share-Based Payment Award, Options, Exercises In Period | 35,008 | 6,583 | 291,667 | |||||||
Proceeds from Stock Options Exercised | $ 41,000 | |||||||||
Prev Abr Llc [Member] | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 655,321 | |||||||||
Equity Issued in Business Combination, Fair Value Disclosure | $ 1,350,000 | |||||||||
Cedars-Sinai Medical Center [Member] | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Stock Issued During Period, Shares, Acquisitions | 334,911 | |||||||||
Equity Issued in Business Combination, Fair Value Disclosure | $ 425,000 | |||||||||
Sale of Stock for Channel Agreement Price, Per Share | $ 1.27 | |||||||||
Warrant [Member] | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Stock Issued During Period Shares Cash less Warrant Exercises | 232,619 | |||||||||
IPO [Member] | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 14,059,616 | |||||||||
Common Stock, Closing Price, Per Share | $ 1.47 | |||||||||
Noninterest Expense Offering Cost | $ 1,600,000 | |||||||||
Proceeds from Issuance Initial Public Offering | 20,700,000 | |||||||||
Proceeds from Issuance or Sale of Equity | $ 19,100,000 | |||||||||
Private Placement [Member] | ||||||||||
Stockholders Equity [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 13,225,000 | 15,333,333 | ||||||||
Common Stock, Closing Price, Per Share | $ 1 | |||||||||
Noninterest Expense Offering Cost | $ 1,000,000 | $ 3,400,000 | ||||||||
Proceeds from Issuance Initial Public Offering | $ 13,200,000 | 42,600,000 | ||||||||
Gross Proceeds From Issuance Initial Public Offering | 46,000,000 | |||||||||
Stock Issued During Period, Value, New Issues | $ 2,000,000 | |||||||||
Shares Issued, Price Per Share | $ 3 |
Non-controlling Interest (Detai
Non-controlling Interest (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Aug. 31, 2015 | Aug. 29, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Noncontrolling Interest [Line Items] | |||||
Equity Method Investment, Ownership Percentage | 88.50% | ||||
Net Income (Loss) Attributable to Noncontrolling Interest, Total | $ (1,048,000) | $ 0 | $ (1,000) | ||
Noncontrolling Interest, Ownership Percentage by Parent | 11.50% | ||||
Stockholders Equity Attributable to Noncontrolling Interest | $ (1,048,000) | $ 0 | |||
Consolidation, Eliminations [Member] | |||||
Noncontrolling Interest [Line Items] | |||||
Net Income (Loss) Attributable to Noncontrolling Interest, Total | 1,300,000 | ||||
Stockholders Equity Attributable to Noncontrolling Interest | 239,000 | ||||
Dr. Pimentels [Member] | Consolidation, Eliminations [Member] | |||||
Noncontrolling Interest [Line Items] | |||||
Stockholders Equity Attributable to Noncontrolling Interest | $ 505,000 | ||||
Biomics and Mark Pimentel [Member] | |||||
Noncontrolling Interest [Line Items] | |||||
Noncontrolling Interest, Ownership Percentage by Parent | 8.50% | 11.50% | |||
Stock Purchase Agreement [Member] | |||||
Noncontrolling Interest [Line Items] | |||||
Conversion of Stock, Shares Converted | 1,350,000 | ||||
Conversion of Stock, Shares Issued | 1,350,000 | 1,350,000 |
License, Collaborative and Em42
License, Collaborative and Employment Agreements and Commitments (Details) $ in Thousands | Dec. 31, 2015USD ($) |
Other Commitments [Line Items] | |
2,016 | $ 148 |
2,017 | 148 |
2,018 | 152 |
2,019 | 157 |
2,020 | 162 |
Total | 767 |
Lease Agreements [Member] | |
Other Commitments [Line Items] | |
2,016 | 148 |
2,017 | 148 |
2,018 | 152 |
2,019 | 157 |
2,020 | 162 |
Total | $ 767 |
License, Collaborative and Em43
License, Collaborative and Employment Agreements and Commitments (Details Textual) - USD ($) | Dec. 04, 2015 | Aug. 10, 2015 | Aug. 31, 2015 | Aug. 29, 2015 | Aug. 10, 2015 | Apr. 28, 2015 | Mar. 18, 2015 | Feb. 29, 2012 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Research and Development Expense | $ 32,906,000 | $ 14,489,000 | $ 6,507,000 | |||||||||
Operating Leases, Rent Expense | 108,000 | 77,000 | 68,000 | |||||||||
Operating Leases, Future Minimum Payments Due, Next Twelve Months | 148,000 | |||||||||||
Prepaid Expense and Other Assets, Current | 9,519,000 | 1,548,000 | ||||||||||
Payments to Acquire in Process Research and Development | $ 424,000 | $ 293,000 | $ 1,000,000 | |||||||||
Exchange percentage of unregistered common stock | 50.00% | |||||||||||
Proceeds from (Repurchase of) Equity, Total | $ 3,000,000 | |||||||||||
Stock Purchase Agreement [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Conversion of Stock, Shares Converted | 1,350,000 | |||||||||||
Conversion of Stock, Shares Issued | 1,350,000 | 1,350,000 | ||||||||||
Channel Collaboration Agreement [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Shares, Issued | 937,500 | 937,500 | ||||||||||
Stock Issued | $ 3,000,000 | $ 3,000,000 | ||||||||||
Mark Pimentel [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Common stock Outstanding Percentage | 8.50% | |||||||||||
Licensing Agreements [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Payments for Fees | $ 150,000 | |||||||||||
Stock Issued During Period, Shares, New Issues | 334,911 | |||||||||||
Patents [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Payments for Fees | $ 220,000 | |||||||||||
Riley Employment Agreement [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Deferred Compensation Arrangement with Individual, Compensation Expense | $ 550,000 | $ 385,000 | ||||||||||
Deferred Compensation Arrangement with Individual, Cash Awards Granted, Percentage | 75.00% | |||||||||||
Shallcross Employment Agreement [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | 1,900,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 900,000 | |||||||||||
Deferred Compensation Arrangement with Individual, Compensation Expense | $ 315,000 | |||||||||||
Deferred Compensation Arrangement with Individual, Cash Awards Granted, Percentage | 75.00% | |||||||||||
Deferred Compensation Arrangement with Individual, Maximum Contractual Term | 2 years | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent | 50.00% | |||||||||||
Ballantyne Employment Agreement [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Deferred Compensation Arrangement with Individual, Compensation Expense | $ 335,000 | |||||||||||
Deferred Compensation Arrangement with Individual, Cash Awards Granted, Percentage | 75.00% | |||||||||||
Jeffrey Riley [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 1,700,000 | |||||||||||
Officers Compensation | $ 348,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 750,000 | |||||||||||
C. Evan Ballantyne [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 1,000,000 | |||||||||||
Officers Compensation | $ 298,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 425,000 | |||||||||||
Intrexon [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Research and Development Expense | $ 7,800,000 | |||||||||||
Milestone Payment | 27,000,000 | |||||||||||
Stock Issued During Period, Shares, Acquisitions | 3,552,210 | |||||||||||
Prepaid Expense and Other Assets, Current | 2,500,000 | |||||||||||
Shares Issued, Price Per Share | $ 0.001 | |||||||||||
Milestone Payment upon First Dosing | $ 2,000,000 | |||||||||||
Intrexon [Member] | Minimum [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Royalty Revenue, Total | 100,000,000 | |||||||||||
Intrexon [Member] | Maximum [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Royalty Revenue, Total | 750,000,000 | |||||||||||
Intrexon [Member] | Research and Development Arrangement [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Prepaid Expense and Other Assets, Current | $ 643,000 | |||||||||||
Prev Abr Llc [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Additional Cash Payment for License Agreement | $ 235,000 | |||||||||||
Unregistered Shares Issued to License Agreement | 625,000 | |||||||||||
Additional Consideration Payable | 50% in cash and 50% in our stock | |||||||||||
Options To Be Received Common Stock Shares | 655,321 | |||||||||||
Cedars-Sinai Medical Center [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Common stock Outstanding Percentage | 11.50% | |||||||||||
Office Space In Ann Arbor [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Operating Lease Leasing Term | extend the term of the lease to December 31, 2016 | |||||||||||
Operating Leases, Future Minimum Payments Due, Next Twelve Months | $ 40,000 | |||||||||||
Office Space In Rockville [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Operating Lease Leasing Term | sixty-six month operating lease that may be renewed for one additional term of five years | |||||||||||
Operating Annual Lease Payments | $ 142,172 | |||||||||||
December 31, 2014 [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Operating Leases, Future Minimum Payments Due, Next Twelve Months | 50,000 | |||||||||||
December 31, 2015 [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Operating Leases, Future Minimum Payments Due, Next Twelve Months | 25,000 | |||||||||||
Phase I Clinical Trials [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Milestone Payment | 50,000 | |||||||||||
Phase III Clinical Trials [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Milestone Payment | 100,000 | |||||||||||
NDA Submission In US [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Milestone Payment | 250,000 | |||||||||||
European Medicines Agency Approval [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Milestone Payment | 100,000 | |||||||||||
Regulatory Approval In Asian Country [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Milestone Payment | $ 100,000 | |||||||||||
IND Milestone Event [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Registration Payment Arrangement, Settlement Alternatives | The Company also agreed upon the filing of an IND application with the FDA for a Synthetic Product, or alternatively the filing of the first equivalent regulatory filing with a foreign regulatory agency (both as applicable, the IND Milestone Event), to pay Intrexon either (i) $2.0 million in cash, or (ii) that number of shares of Common Stock (the IND Milestone Shares) having a fair market value equaling $2.0 million where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the IND Milestone Event. | |||||||||||
Approval Milestone Event [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Registration Payment Arrangement, Settlement Alternatives | Upon the first to occur of either first commercial sale of a Synthetic Product in a country or the granting of the regulatory approval of that Synthetic Product (both as applicable, the Approval Milestone Event), the Company agreed to pay to Intrexon either (i) $3.0 million in cash, or (ii) that number of shares of Common Stock (the Approval Milestone Shares) having a fair market value equaling $3.0 million where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the Approval Milestone Event. | |||||||||||
Field Expansion Fee [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Registration Payment Arrangement, Settlement Alternatives | The Field Expansion Fee must be paid completely in either Common Stock or cash, and will comprise either (i) $2.0 million in cash for each target in excess of three total that the Company elects, or (ii) that number of shares of Common Stock (the Field Expansion Fee Shares) having a fair market value equaling $2.0 million for each such target that the Company elects in excess of three where such fair market value is determined using published market data establishing the volume-weighted average price for a share of Common Stock over the 30 day period immediately preceding the date of the Field Expansion Fee Closing. | |||||||||||
First Year [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Research Agreement Fixed Fee | $ 303,287 | |||||||||||
Second Year [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Research Agreement Fixed Fee | 316,438 | |||||||||||
Third Year [Member] | ||||||||||||
License, Collaborative and Employment Agreements and Commitments [Line Items] | ||||||||||||
Research Agreement Fixed Fee | $ 328,758 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Components Of Income Tax Expense Benefit [Line Items] | ||
Computed “expected” tax-benefit - Federal | $ (14,870) | $ (6,727) |
Computed “expected” tax-benefit - State | (1,732) | (783) |
Adjustment of “expected” tax-benefit to actual | 199 | (687) |
Meals, entertainment and other | 8 | 13 |
Non-deductible stock-based compensation | 877 | 789 |
Fair Market Value adjustment - Warrants | 1,447 | (235) |
Change in valuation allowance | 14,071 | 7,630 |
Income tax expense | $ 0 | $ 0 |
Income Taxes (Details 1)
Income Taxes (Details 1) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets: | ||
Stock issued for services | $ 922 | $ 585 |
Accrued compensation | 105 | 0 |
Stock issued for acquisition of program | 1,787 | 949 |
Stock issued for license agreement | 2,308 | 2,507 |
Net operating loss carry-forward | 37,852 | 24,657 |
Total gross deferred tax assets | 42,974 | 28,698 |
Less: valuation allowance | (42,974) | (28,698) |
Total net deferred tax assets | $ 0 | $ 0 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax [Line Items] | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 34.00% | 34.00% | 34.00% |
Effective Income Tax Rate Reconciliation, State and Local Income Taxes, Percent | 3.96% | 3.96% | 3.96% |
Effective Income Tax Rate Reconciliation, Change in Enacted Tax Rate, Percent | 37.96% | 37.96% | 37.96% |
Valuation Allowance, Deferred Tax Asset, Change in Amount | $ 14,071 | $ 7,630 | |
Deferred Tax Assets, Valuation Allowance | 42,974 | $ 28,698 | |
Operating Loss Carryforwards | $ 99,400 | ||
Operating Loss Carryforwards Expire Date | 2,035 |
Related Party Transactions (Det
Related Party Transactions (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Dec. 31, 2012 | Dec. 31, 2015 | Aug. 07, 2015 | Dec. 31, 2014 | Aug. 31, 2012 | Nov. 30, 2011 | |
Related Party Transaction [Line Items] | ||||||
Common Stock, Shares, Issued | 90,908,234 | 72,594,626 | ||||
Common Stock, Value, Issued | $ 91 | $ 72 | ||||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | ||||
Intrexon [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Common Stock, Shares, Issued | 937,500 | 3,552,210 | 3,123,558 | |||
Common Stock, Value, Issued | $ 3,000 | $ 7,800 | $ 1,700 | |||
Common Stock, Par or Stated Value Per Share | $ 2.20 | $ 0.54 | ||||
Costs and Expenses, Related Party | $ 2,900 | |||||
Intrexon [Member] | Research and Development Expense [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Costs and Expenses, Related Party | $ 2,500 |
Selected Quarterly Financial 48
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Selected Quarterly Financial Information [Line Items] | |||||||||||
Loss from operations | $ (11,393) | $ (11,650) | $ (9,730) | $ (8,207) | $ (7,101) | $ (4,911) | $ (4,651) | $ (3,839) | |||
Net loss | $ (11,296) | $ (7,507) | $ (13,623) | $ (12,359) | $ (6,480) | $ (4,910) | $ (4,556) | $ (3,838) | $ (43,737) | $ (19,784) | $ (12,317) |
Net loss per share - basic (in dollars per share) | $ (0.12) | $ (0.08) | $ (0.19) | $ (0.17) | |||||||
Net loss per share - dilutive (in dollars per share) | $ (0.12) | $ (0.12) | $ (0.19) | $ (0.17) | |||||||
Weighted average common share - basic (in shares) | 90,810,629 | 85,974,751 | 72,736,829 | 72,673,959 | |||||||
Weighted average common share - dilutive (in shares) | 90,810,629 | 87,585,103 | 72,736,829 | 72,673,959 | |||||||
Net loss per share - basic and dilutive (in dollars per share) | $ (0.10) | $ (0.08) | $ (0.08) | $ (0.07) | $ (0.54) | $ (0.32) | $ (0.27) | ||||
Weighted average common share - basic and dilutive (in shares) | 65,483,336 | 58,543,528 | 58,543,528 | 58,324,260 | 80,705,692 | 61,945,356 | 45,667,813 |